<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02983552</url>
  </required_header>
  <id_info>
    <org_study_id>ATS20</org_study_id>
    <secondary_id>2U10EY011751</secondary_id>
    <nct_id>NCT02983552</nct_id>
  </id_info>
  <brief_title>Binocular Dig Rush Game Treatment for Amblyopia</brief_title>
  <acronym>ATS20</acronym>
  <official_title>Binocular Dig Rush Game Treatment for Amblyopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pediatric Eye Disease Investigator Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Jaeb Center for Health Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle&#xD;
      correction with spectacle correction only, for treatment of amblyopia in children 4 to &lt;13&#xD;
      years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5&#xD;
      days per week plus spectacle correction with spectacle correction only, for treatment of&#xD;
      amblyopia in children 4 to &lt;13 years of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">July 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.&#xD;
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort</measure>
    <time_frame>baseline and 4 weeks</time_frame>
    <description>The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.&#xD;
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VA Improvement at 4 Weeks Defined as a Binary Outcome</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VA Improvement at 8 Weeks Defined as a Binary Outcome</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Stereoacuity Scores at 4 Weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Stereoacuity Scores From Baseline</measure>
    <time_frame>4 weeks</time_frame>
    <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Stereoacuity Scores at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Stereoacuity Scores From Baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast</measure>
    <time_frame>4 weeks</time_frame>
    <description>Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of &gt;75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast</measure>
    <time_frame>8 weeks</time_frame>
    <description>Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Compliance With Spectacle Wear</measure>
    <time_frame>4 weeks</time_frame>
    <description>Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed &gt;75% of spectacle wear at 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Compliance With Spectacle Wear</measure>
    <time_frame>8 weeks</time_frame>
    <description>Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed &gt;75% of spectacle wear at 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Alignment at 4 Weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.&#xD;
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).&#xD;
Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Alignment at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test.&#xD;
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).&#xD;
Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)</measure>
    <time_frame>4 weeks</time_frame>
    <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)</measure>
    <time_frame>4 weeks</time_frame>
    <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Adverse Symptoms (Symptom Survey)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted. Positive values for visual acuity change indicate improvement.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Binocular Computer Game Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continued Spectacle Correction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iPad®</intervention_name>
    <description>Binocular therapy using a Dig Rush application on an iPad®</description>
    <arm_group_label>Binocular Computer Game Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spectacle correction</intervention_name>
    <description>Spectacle correction for all waking hours, 7 days per week</description>
    <arm_group_label>Continued Spectacle Correction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 4 to &lt;13 years&#xD;
&#xD;
          2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or&#xD;
             untreated)&#xD;
&#xD;
               1. Criteria for strabismic amblyopia: At least one of the following must be met:&#xD;
&#xD;
                    -  Presence of a heterotropia on examination at distance or near fixation (with&#xD;
                       or without optical correction, must be no more than 5pd by SPCT at near&#xD;
                       fixation (see #6 below)&#xD;
&#xD;
                    -  Documented history of strabismus which is no longer present (which in the&#xD;
                       judgment of the investigator could have caused amblyopia)&#xD;
&#xD;
               2. Criteria for anisometropia: At least one of the following criteria must be met:&#xD;
&#xD;
                    -  ≥1.00 D difference between eyes in spherical equivalent&#xD;
&#xD;
                    -  ≥1.50 D difference in astigmatism between corresponding meridians in the two&#xD;
                       eyes&#xD;
&#xD;
               3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be&#xD;
                  met:&#xD;
&#xD;
                    -  Criteria for strabismus are met (see above)&#xD;
&#xD;
                    -  ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D&#xD;
                       difference in astigmatism between corresponding meridians in the two eyes&#xD;
&#xD;
          3. No amblyopia treatment other than optical correction in the past 2 weeks (patching,&#xD;
             atropine, Bangerter, vision therapy, binocular treatment)&#xD;
&#xD;
          4. Requirements for required refractive error correction (based on a cycloplegic&#xD;
             refraction completed within the last 7 months):&#xD;
&#xD;
               -  Hypermetropia of 2.50 D or more by spherical equivalent (SE)&#xD;
&#xD;
               -  Myopia of amblyopic eye of 0.50D or more SE&#xD;
&#xD;
               -  Astigmatism of 1.00D or more&#xD;
&#xD;
               -  Anisometropia of more than 0.50D SE&#xD;
&#xD;
             NOTE: Subjects with cycloplegic refractive errors that do not fall within the&#xD;
             requirements above for spectacle correction may be given spectacles at investigator&#xD;
             discretion but must follow the study-specified prescribing guidelines, as detailed&#xD;
             below.&#xD;
&#xD;
               1. Spectacle prescribing instructions referenced to the cycloplegic refraction&#xD;
                  completed within the last 7 months:&#xD;
&#xD;
                    -  SE must be within 0.50D of fully correcting the anisometropia.&#xD;
&#xD;
                    -  SE must not be under corrected by more than 1.50D SE, and reduction in plus&#xD;
                       sphere must be symmetric in the two eyes.&#xD;
&#xD;
                    -  Cylinder power in both eyes must be within 0.50D of fully correcting the&#xD;
                       astigmatism.&#xD;
&#xD;
                    -  Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within&#xD;
                       +/- 5 degrees if cylinder power is &gt;1.00D.&#xD;
&#xD;
                    -  Myopia must not be undercorrected by more than 0.25D or over corrected by&#xD;
                       more than 0.50D SE, and any change must be symmetrical in the two eyes.&#xD;
&#xD;
               2. Spectacle correction meeting the above criteria must be worn:&#xD;
&#xD;
                    -  For at least 16 weeks OR until VA stability is documented (defined as &lt;0.1&#xD;
                       logMAR change by the same testing method measured on 2 consecutive exams at&#xD;
                       least 8 weeks apart).&#xD;
&#xD;
                    -  For determining VA stability (non-improvement):&#xD;
&#xD;
                         -  The first of two measurements may be made 1) in current spectacles, or&#xD;
                            2) in trial frames with or without cycloplegia or 3) without correction&#xD;
                            (if new correction is prescribed),&#xD;
&#xD;
                         -  The second measurement must be made without cycloplegia in the correct&#xD;
                            spectacles that have been worn for at least 8 weeks.&#xD;
&#xD;
                         -  Note: since this determination is a pre-study procedure, the method of&#xD;
                            measuring VA is not mandated.&#xD;
&#xD;
          5. VA, measured in each eye without cycloplegia in current spectacle correction (if&#xD;
             applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for&#xD;
             children &lt; 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a&#xD;
             study-approved device displaying single surrounded optotypes, as follows:&#xD;
&#xD;
               1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters&#xD;
                  (E-ETDRS)&#xD;
&#xD;
               2. VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)&#xD;
&#xD;
               3. Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)&#xD;
&#xD;
          6. Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction&#xD;
             (Angles of ocular deviation &gt;5∆ are not allowed because large magnitudes of the&#xD;
             deviation would compromise successful playing of the game.)&#xD;
&#xD;
          7. Subject is able to play the Dig Rush game (at least level 3) on the study iPad under&#xD;
             binocular conditions (with red-green glasses). Subject must be able to see both the&#xD;
             red &quot;diggers&quot; and blue &quot;gold carts&quot; when contrast for the non-amblyopic eye is at 20%.&#xD;
&#xD;
          8. Investigator is willing to prescribe computer game play, or continued spectacle wear&#xD;
             per protocol.&#xD;
&#xD;
          9. Parent understands the protocol and is willing to accept randomization.&#xD;
&#xD;
         10. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center&#xD;
             staff or other study staff.&#xD;
&#xD;
         11. Relocation outside of area of an active PEDIG site for this study within the next 8&#xD;
             weeks is not anticipated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prism in the spectacle correction at time of enrollment (eligible only if prism is&#xD;
             discontinued 2 weeks prior to enrollment).&#xD;
&#xD;
          2. Myopia greater than -6.00D spherical equivalent in either eye.&#xD;
&#xD;
          3. Previous intraocular or refractive surgery.&#xD;
&#xD;
          4. Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or&#xD;
             previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is&#xD;
             allowed regardless of type, but must be discontinued at least 2 weeks prior to&#xD;
             enrollment.&#xD;
&#xD;
          5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed&#xD;
             within the past 7 months (Note: nystagmus per se does not exclude the subject if the&#xD;
             above VA criteria are met).&#xD;
&#xD;
          6. No Down syndrome or cerebral palsy&#xD;
&#xD;
          7. No severe developmental delay that would interfere with treatment or evaluation (in&#xD;
             the opinion of the investigator). Subjects with mild speech delay or reading and/or&#xD;
             learning disabilities are not excluded.&#xD;
&#xD;
          8. Subject has demonstrated previous low compliance with binocular treatment and/or&#xD;
             spectacle treatment (as assessed informally by the investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Manny, OD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Houston College of Optometry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan Holmes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Pediatric Eye Care; Birmingham Health Care</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwestern University Eye Institute</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Eye Center at Ketchum Health</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Health Care, Dept. of Ophthalmology</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saddleback Eye Medical Associates</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western University College of Optometry</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Southeastern University College of Optometry, The Eye Institute</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33382</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Emory Eye Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Luke's Hospital</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ticho Eye Associates</name>
      <address>
        <city>Chicago Ridge</city>
        <state>Illinois</state>
        <zip>60415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois College of Optometry</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Eye Care</name>
      <address>
        <city>Lisle</city>
        <state>Illinois</state>
        <zip>60532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Vision Center</name>
      <address>
        <city>Schaumburg</city>
        <state>Illinois</state>
        <zip>60194</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Eye Associates</name>
      <address>
        <city>Wilmette</city>
        <state>Illinois</state>
        <zip>60091</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana School of Optometry</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolfe Eye Clinic</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204-5809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan College of Optometry at Ferris State Univ</name>
      <address>
        <city>Big Rapids</city>
        <state>Michigan</state>
        <zip>49307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital Pediatric Ophthalmology</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Ophthalmology, P.C.</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota-Minnesota Lions Children's Eye Clinic</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospitals and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University Institute</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital Eye Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U of MO St. Louis College of Optometry</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Ophthalmologic Associates</name>
      <address>
        <city>Concord</city>
        <state>New Hampshire</state>
        <zip>03301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael F. Gallaway, O.D., P.C.</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State University of New York, College of Optometry</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Eye Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Ophthalmology Associates, Inc.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University College of Optometry</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210-1280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Associates, Inc.</name>
      <address>
        <city>Poland</city>
        <state>Ohio</state>
        <zip>44514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean A. McGee Eye Institute, University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific University College of Optometry</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Casey Eye Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Ophthalmology of Erie</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Conestoga Eye</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Eye Specialists</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern College of Optometry</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital - Dept. Of Ophthalmology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Houston College of Optometry</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Science Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Eye Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Eye Associates</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Pediatric Eye Center</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital, University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Pediatric Ophthalmology, P.S.</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spokane Eye Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshall University</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin, University Station</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Snowy Range Vision Center</name>
      <address>
        <city>Laramie</city>
        <state>Wyoming</state>
        <zip>82070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22.</citation>
    <PMID>30352226</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>December 17, 2020</results_first_submitted>
  <results_first_submitted_qc>June 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 11, 2021</results_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Amblyopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.</ipd_description>
    <ipd_time_frame>Data will be made available after publication of each primary manuscript.</ipd_time_frame>
    <ipd_access_criteria>Users accessing the data must enter an email address.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT02983552/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT02983552/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT02983552/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>138 is the number of subjects from the older cohort study. 182 is the number of subjects from the younger cohort.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Binocular Computer Game Treatment- Older Cohort</title>
          <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
        </group>
        <group group_id="P2">
          <title>Continued Spectacle Correction- Older Cohort</title>
          <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
        </group>
        <group group_id="P3">
          <title>Binocular Computer Game Treatment- Younger Cohort</title>
          <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
        </group>
        <group group_id="P4">
          <title>Continued Spectacle Correction- Younger Cohort</title>
          <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="92"/>
                <participants group_id="P4" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>4 Week Visit</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="67"/>
                <participants group_id="P3" count="85"/>
                <participants group_id="P4" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>8 Week Visit</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="85"/>
                <participants group_id="P4" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>16 Week Visit</title>
              <participants_list>
                <participants group_id="P1" count="0">The 16 week visit was elective for those who were originally assigned to continued spectacle correction. After completing 8 weeks of continued spectacle correction, participants were able to complete 8 weeks of binocular therapy. Values are not provided for the binocular computer game treatment cohorts as this visit was not applicable.</participants>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="0">The 16 week visit was elective for those who were originally assigned to continued spectacle correction. After completing 8 weeks of continued spectacle correction, participants were able to complete 8 weeks of binocular therapy. Values are not provided for the binocular computer game treatment cohorts as this visit was not applicable.</participants>
                <participants group_id="P4" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="67"/>
                <participants group_id="P3" count="92"/>
                <participants group_id="P4" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Binocular Computer Game Treatment Older Cohort</title>
          <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
        </group>
        <group group_id="B2">
          <title>Continued Spectacle Correction Older Cohort</title>
          <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
        </group>
        <group group_id="B3">
          <title>Binocular Computer Game Treatment Younger Cohort</title>
          <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
        </group>
        <group group_id="B4">
          <title>Continued Spectacle Correction Younger Cohort</title>
          <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="92"/>
            <count group_id="B4" value="90"/>
            <count group_id="B5" value="320"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="90"/>
                    <measurement group_id="B5" value="320"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.6" spread="1.6"/>
                    <measurement group_id="B2" value="9.6" spread="1.5"/>
                    <measurement group_id="B3" value="5.8" spread="0.7"/>
                    <measurement group_id="B4" value="5.7" spread="0.7"/>
                    <measurement group_id="B5" value="7.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age Range</title>
              <category_list>
                <category>
                  <title>7 to &lt;10 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10 to &lt;13 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 to &lt;5 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 to &lt;6 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 to &lt;7 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="74"/>
                    <measurement group_id="B5" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown/not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Amblyopia Treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patching</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Atropine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patching/Atropine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patching/Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patching/Atropine/Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Binocular Treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance Amblyopic-eye VA (Letter Score)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>20/160</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/125</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/100</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/80</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/63</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/50</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/40</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20/200</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance Amblyopic-eye VA</title>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.50" spread="0.16"/>
                    <measurement group_id="B2" value="0.52" spread="0.16"/>
                    <measurement group_id="B3" value="0.48" spread="0.16"/>
                    <measurement group_id="B4" value="0.48" spread="0.17"/>
                    <measurement group_id="B5" value="0.49" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance Fellow-eye VA</title>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-0.058" spread="0.079"/>
                    <measurement group_id="B2" value="-0.058" spread="0.074"/>
                    <measurement group_id="B3" value="0.002" spread="0.083"/>
                    <measurement group_id="B4" value="-0.003" spread="0.085"/>
                    <measurement group_id="B5" value="-0.025" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Interocular Difference (Lines)</title>
          <units>Lines</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.57" spread="1.83"/>
                    <measurement group_id="B2" value="5.75" spread="1.86"/>
                    <measurement group_id="B3" value="4.80" spread="4.86"/>
                    <measurement group_id="B4" value="1.71" spread="1.70"/>
                    <measurement group_id="B5" value="5.19" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stereoacuity: Nil</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stereoacuity (Seconds of Arc)</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measured as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool (scores: 800, 400, 200, 100, 60 and 40) stereoacuity test methods as previously described. Lower scores indicate better stereoacuity.&#xD;
A logarithm base 10 transformation was used to convert stereoacuity scores (Nil was assigned a score of 4000) to the log scale to calculate descriptive statistics (reported as seconds of arc).</description>
          <units>Seconds of Arc</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2000" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B2" value="2000" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B3" value="800" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B4" value="800" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B5" value="2000" lower_limit="40" upper_limit="4000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Amblyopia Cause</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Strabismus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Anisometropia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="181"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Combined-mechanism</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance SPCT: Maximum angle of deviation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Orthotropic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="76"/>
                    <measurement group_id="B5" value="246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 to 4 prism diopters</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 to 9 prism diopters</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=10 prism diopters</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Near SPCT: Maximum angle of deviation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Orthotropic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="72"/>
                    <measurement group_id="B4" value="75"/>
                    <measurement group_id="B5" value="238"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 to 4 prism diopters</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Amblyopic-eye Spherical Equivalent (Diopters)</title>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.35" spread="2.42"/>
                    <measurement group_id="B2" value="4.40" spread="2.28"/>
                    <measurement group_id="B3" value="4.49" spread="1.75"/>
                    <measurement group_id="B4" value="4.45" spread="2.76"/>
                    <measurement group_id="B5" value="4.43" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fellow-eye Spherical Equivalent (Diopters)</title>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.10" spread="2.12"/>
                    <measurement group_id="B2" value="2.22" spread="1.99"/>
                    <measurement group_id="B3" value="2.41" spread="1.67"/>
                    <measurement group_id="B4" value="2.67" spread="1.99"/>
                    <measurement group_id="B5" value="2.38" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Spherical Equivalent Anisometropia (Diopters)</title>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.29" spread="1.79"/>
                    <measurement group_id="B2" value="2.27" spread="1.62"/>
                    <measurement group_id="B3" value="2.12" spread="1.52"/>
                    <measurement group_id="B4" value="2.25" spread="1.51"/>
                    <measurement group_id="B5" value="2.22" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort</title>
        <description>The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.&#xD;
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort</title>
          <description>The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.&#xD;
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.</description>
          <units>Letter score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.1" upper_limit="2.6"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.4" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.1" upper_limit="2.6"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.4" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.71</p_value>
            <p_value_desc>a priori threshold for statistical significance: 2-sided type I error rate of 5%</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Adjusted for baseline amblyopic-eye visual acuity.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 4 week visit.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
          <units>Letter score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="10.5"/>
                    <measurement group_id="O2" value="28.0" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
        <time_frame>Baseline and 8 weeks</time_frame>
        <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
          <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
          <units>Letters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.7" upper_limit="3.9"/>
                    <measurement group_id="O2" value="2.4" lower_limit="0.8" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.6" upper_limit="4.0"/>
                    <measurement group_id="O2" value="2.4" lower_limit="0.9" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>98.3</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.4</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
            <estimate_desc>A 2-sided 98.3% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 8-week visit.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
        <time_frame>8 weeks</time_frame>
        <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.</description>
          <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
          <units>Letter score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="9.9"/>
                    <measurement group_id="O2" value="27.7" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort</title>
        <description>The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.&#xD;
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.</description>
        <time_frame>baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort</title>
          <description>The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.&#xD;
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.</description>
          <units>logMAR Lines</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0724" lower_limit="0.8" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.6053" lower_limit="0.3" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0706" lower_limit="0.8" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.6071" lower_limit="0.3" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.22"/>
                    <measurement group_id="O2" value="0.42" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
        <time_frame>Baseline and 8 weeks</time_frame>
        <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
          <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
          <units>logMAR Lines</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2614" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="0.9855" lower_limit="0.7" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2588" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="0.9981" lower_limit="0.7" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
        <time_frame>8 weeks</time_frame>
        <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.&#xD;
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.</description>
          <population>Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to &lt;105 days from randomization).</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.22"/>
                    <measurement group_id="O2" value="0.38" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VA Improvement at 4 Weeks Defined as a Binary Outcome</title>
        <description>A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>VA Improvement at 4 Weeks Defined as a Binary Outcome</title>
          <description>A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2</param_value>
            <ci_percent>98.3</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13</ci_lower_limit>
            <ci_upper_limit>9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VA Improvement at 8 Weeks Defined as a Binary Outcome</title>
        <description>A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.</description>
        <time_frame>At 8 weeks</time_frame>
        <population>Of 68 participants in the continued spectacle correction older cohort, only 67 visits were completed in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>VA Improvement at 8 Weeks Defined as a Binary Outcome</title>
          <description>A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.</description>
          <population>Of 68 participants in the continued spectacle correction older cohort, only 67 visits were completed in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1</param_value>
            <ci_percent>98.3</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15</ci_lower_limit>
            <ci_upper_limit>12</ci_upper_limit>
            <other_analysis_desc>For secondary visual acuity outcomes, which included the 8-week treatment group comparison, a Bonferroni adjustment was used to control for multiple testing (3 outcomes tested) to preserve the overall type I error rate at 5% (2-sided alpha=0.017 per test).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Stereoacuity Scores at 4 Weeks</title>
        <description>Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
        <time_frame>4 weeks</time_frame>
        <population>Limited to those with follow-up visits completed within the pre-specified analysis window</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Stereoacuity Scores at 4 Weeks</title>
          <description>Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
          <population>Limited to those with follow-up visits completed within the pre-specified analysis window</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Missing/Not done</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nil</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2000</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>800</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>400</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>200</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>100</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Change in Stereoacuity Scores From Baseline</title>
        <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
        <time_frame>4 weeks</time_frame>
        <population>Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Stereoacuity Scores From Baseline</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
          <population>Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>2 or more levels worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Within 1 level</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="56"/>
                    <measurement group_id="O4" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 or more levels better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.38</p_value>
            <p_value_desc>The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Stereoacuity Scores at 8 Weeks</title>
        <description>Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
        <time_frame>8 weeks</time_frame>
        <population>Limited to those with follow-up visits completed within the pre-specified analysis window</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Stereoacuity Scores at 8 Weeks</title>
          <description>Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
          <population>Limited to those with follow-up visits completed within the pre-specified analysis window</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>800</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>400</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Change in Stereoacuity Scores From Baseline</title>
        <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.</description>
        <time_frame>8 weeks</time_frame>
        <population>Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Stereoacuity Scores From Baseline</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.</description>
          <population>Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 or more levels worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1 level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 or more levels better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.53</p_value>
            <p_value_desc>The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</title>
        <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
        <time_frame>4 weeks</time_frame>
        <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
          <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Missing/Not Done</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nil</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2000</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>800</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>400</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>200</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>100</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</title>
        <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
        <time_frame>4 weeks</time_frame>
        <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title. Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
          <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title. Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 or more levels worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1 level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 or more levels better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <p_value_desc>The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group for participants without strabismus.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</title>
        <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
        <time_frame>8 weeks</time_frame>
        <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.&#xD;
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.</description>
          <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>800</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>400</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</title>
        <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
        <time_frame>8 weeks</time_frame>
        <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</title>
          <description>Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.</description>
          <population>Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 or more levels worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1 level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 or more levels better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.74</p_value>
            <p_value_desc>The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group for participants without strabismus.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast</title>
        <description>Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of &gt;75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.</description>
        <time_frame>4 weeks</time_frame>
        <population>The control group was not prescribed binocular therapy, which is why they were not included here.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast</title>
          <description>Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of &gt;75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.</description>
          <population>The control group was not prescribed binocular therapy, which is why they were not included here.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completed &gt;75% prescribed game play</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 20% or worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast</title>
        <description>Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.</description>
        <time_frame>8 weeks</time_frame>
        <population>Data from automated iPad log files were only able to be retrieved successfully for 81 of 85 participants in the younger cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast</title>
          <description>Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.</description>
          <population>Data from automated iPad log files were only able to be retrieved successfully for 81 of 85 participants in the younger cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completed &gt;75% prescribed game play</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 20% or worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Compliance With Spectacle Wear</title>
        <description>Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed &gt;75% of spectacle wear at 4 weeks.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Compliance With Spectacle Wear</title>
          <description>Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed &gt;75% of spectacle wear at 4 weeks.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Compliance With Spectacle Wear</title>
        <description>Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed &gt;75% of spectacle wear at 8 weeks.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Compliance With Spectacle Wear</title>
          <description>Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed &gt;75% of spectacle wear at 8 weeks.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="89"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="69"/>
                    <measurement group_id="O4" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)</title>
        <description>The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)</title>
          <description>The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
          <units>Letters</units>
          <param>Mean</param>
          <dispersion>99% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-1.1" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.1" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-1.1" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.2" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
            <estimate_desc>Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)</title>
        <description>The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)</title>
          <description>The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
          <units>Letters</units>
          <param>Mean</param>
          <dispersion>99% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="-0.5" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.5" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="-0.6" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.7" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.0</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Alignment at 4 Weeks</title>
        <description>The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.&#xD;
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).&#xD;
Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.</description>
        <time_frame>4 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Alignment at 4 Weeks</title>
          <description>The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.&#xD;
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).&#xD;
Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.37</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Alignment at 8 Weeks</title>
        <description>The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test.&#xD;
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).&#xD;
Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.</description>
        <time_frame>8 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Alignment at 8 Weeks</title>
          <description>The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test.&#xD;
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).&#xD;
Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)</title>
        <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
        <time_frame>4 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)</title>
          <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="78"/>
                    <measurement group_id="O4" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up to 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All the time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>Cochran-Armitage trend test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)</title>
        <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
        <time_frame>8 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)</title>
          <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="78"/>
                    <measurement group_id="O4" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up to 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All the time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Cochran-Armitage trend test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)</title>
        <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.</description>
        <time_frame>4 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)</title>
          <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increased frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Similar frequency (within 1 level)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="79"/>
                    <measurement group_id="O4" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduced frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.44</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)</title>
        <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.</description>
        <time_frame>8 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)</title>
          <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increased frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Similar frequency (within 1 level)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="82"/>
                    <measurement group_id="O4" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduced frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)</title>
        <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
        <time_frame>4 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)</title>
          <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="87"/>
                    <measurement group_id="O4" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up to 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All the time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Cochran-Armitage trend test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)</title>
        <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
        <time_frame>8 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)</title>
          <description>The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.&#xD;
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="84"/>
                    <measurement group_id="O4" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up to 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All the time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Cochran-Armitage trend test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)</title>
        <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.</description>
        <time_frame>4 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)</title>
          <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increased frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Similar frequency (within 1 level)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="88"/>
                    <measurement group_id="O4" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduced frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)</title>
        <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.</description>
        <time_frame>8 weeks</time_frame>
        <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)</title>
          <description>A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.</description>
          <population>As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increased frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Similar frequency (within 1 level)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="68"/>
                    <measurement group_id="O3" value="86"/>
                    <measurement group_id="O4" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduced frequency (≥ 2 levels)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Adverse Symptoms (Symptom Survey)</title>
        <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
        <time_frame>4 weeks</time_frame>
        <population>There were 3 participants in the older cohort control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Adverse Symptoms (Symptom Survey)</title>
          <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
          <population>There were 3 participants in the older cohort control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blurred Vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyestrain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="53"/>
                    <measurement group_id="O4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Look Over Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Take Off Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks</title>
        <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
        <time_frame>8 weeks</time_frame>
        <population>There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks</title>
          <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
          <population>There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blurred Vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="74"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyestrain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="62"/>
                    <measurement group_id="O4" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Look Over Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Take Off Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="45"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Often</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks</title>
        <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
        <time_frame>4 weeks</time_frame>
        <population>There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks</title>
          <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
          <population>There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blurred Vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="73"/>
                    <measurement group_id="O4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyestrain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="73"/>
                    <measurement group_id="O4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Look Over Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Take Off Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="78"/>
                    <measurement group_id="O4" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks</title>
        <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
        <time_frame>8 weeks</time_frame>
        <population>There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items. One participant in the binocular treatment group did not have a completed Symptom Survey at the 8-week visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks</title>
          <description>The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.</description>
          <population>There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items. One participant in the binocular treatment group did not have a completed Symptom Survey at the 8-week visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blurred Vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="67"/>
                    <measurement group_id="O4" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyestrain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="75"/>
                    <measurement group_id="O4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Look Over Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="70"/>
                    <measurement group_id="O4" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Take Off Spectacles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Increased frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Similar frequency (within 1 level)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced frequency (≥ 2 levels)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.06</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)</title>
        <description>The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)</title>
          <description>The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
          <units>logMAR Lines</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0536" lower_limit="-0.1" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.1939" lower_limit="0.02" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0682" lower_limit="-0.1" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.1786" lower_limit="0.02" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)</title>
        <description>The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
        <time_frame>baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)</title>
          <description>The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.</description>
          <units>logMAR Lines</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3160" lower_limit="0.1" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.2122" lower_limit="0.04" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3256" lower_limit="0.1" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.2024" lower_limit="-0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks</title>
        <description>The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted. Positive values for visual acuity change indicate improvement.</description>
        <time_frame>Baseline and 4 weeks</time_frame>
        <population>Analyses were limited to participants who completed the 4-week visit within the pre-defined analysis window (21 to &lt;49 days after randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Computer Game Treatment Older Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O2">
            <title>Continued Spectacle Correction Older Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Computer Game Treatment Younger Cohort</title>
            <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
          </group>
          <group group_id="O4">
            <title>Continued Spectacle Correction Younger Cohort</title>
            <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks</title>
          <description>The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted. Positive values for visual acuity change indicate improvement.</description>
          <population>Analyses were limited to participants who completed the 4-week visit within the pre-defined analysis window (21 to &lt;49 days after randomization).</population>
          <units>Letters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="5.3"/>
                    <measurement group_id="O2" value="1.7" spread="5.5"/>
                    <measurement group_id="O3" value="1.1" spread="1.4"/>
                    <measurement group_id="O4" value="0.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex: Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="4.6"/>
                    <measurement group_id="O2" value="1.8" spread="6.0"/>
                    <measurement group_id="O3" value="1.2" spread="1.4"/>
                    <measurement group_id="O4" value="0.7" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex: Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="38"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="5.8"/>
                    <measurement group_id="O2" value="1.6" spread="4.9"/>
                    <measurement group_id="O3" value="1.0" spread="1.4"/>
                    <measurement group_id="O4" value="0.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at Randomization: 4 to &lt;5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.8" spread="1.2"/>
                    <measurement group_id="O4" value="0.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at Randomization: 5 to &lt;7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.1" spread="1.5"/>
                    <measurement group_id="O4" value="0.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at Randomization: 7 to &lt;10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="6.0"/>
                    <measurement group_id="O2" value="2.0" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at Randomization: 10 to &lt;13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="3.8"/>
                    <measurement group_id="O2" value="1.2" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race: Non-white/Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="6.8"/>
                    <measurement group_id="O2" value="3.7" spread="7.2"/>
                    <measurement group_id="O3" value="1.1" spread="1.3"/>
                    <measurement group_id="O4" value="0.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race: White/Non-Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="4.6"/>
                    <measurement group_id="O2" value="1.2" spread="4.8"/>
                    <measurement group_id="O3" value="1.1" spread="1.5"/>
                    <measurement group_id="O4" value="0.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline VA: 20/080 to 20/200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="5.9"/>
                    <measurement group_id="O2" value="1.3" spread="6.5"/>
                    <measurement group_id="O3" value="1.0" spread="1.3"/>
                    <measurement group_id="O4" value="0.7" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline VA: 20/063</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="3.7"/>
                    <measurement group_id="O2" value="2.5" spread="5.5"/>
                    <measurement group_id="O3" value="0.9" spread="1.5"/>
                    <measurement group_id="O4" value="0.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline VA: 20/050</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="25"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="4.2"/>
                    <measurement group_id="O2" value="0.9" spread="3.3"/>
                    <measurement group_id="O3" value="1.4" spread="1.5"/>
                    <measurement group_id="O4" value="0.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline VA: 20/040</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="5.9"/>
                    <measurement group_id="O2" value="2.2" spread="4.5"/>
                    <measurement group_id="O3" value="1.1" spread="1.5"/>
                    <measurement group_id="O4" value="0.9" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Amblyopia Treatment: No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="3.0"/>
                    <measurement group_id="O2" value="5.0" spread="5.7"/>
                    <measurement group_id="O3" value="0.9" spread="1.1"/>
                    <measurement group_id="O4" value="0.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Amblyopia Treatment: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="5.4"/>
                    <measurement group_id="O2" value="1.6" spread="5.5"/>
                    <measurement group_id="O3" value="1.2" spread="1.6"/>
                    <measurement group_id="O4" value="0.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Binocular Treatment: No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="5.3"/>
                    <measurement group_id="O2" value="2.2" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Binocular Treatment: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0"/>
                    <measurement group_id="O2" value="-5.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline stereoacuity at near: Nil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="5.5"/>
                    <measurement group_id="O2" value="0.7" spread="5.6"/>
                    <measurement group_id="O3" value="0.9" spread="1.6"/>
                    <measurement group_id="O4" value="0.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline stereoacuity at near: Better than Nil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="5.2"/>
                    <measurement group_id="O2" value="2.5" spread="5.2"/>
                    <measurement group_id="O3" value="1.2" spread="1.4"/>
                    <measurement group_id="O4" value="0.8" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Near Heterotropia at Randomization: No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="5.2"/>
                    <measurement group_id="O2" value="2.2" spread="5.6"/>
                    <measurement group_id="O3" value="1.1" spread="1.5"/>
                    <measurement group_id="O4" value="0.7" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Near Heterotropia at Randomization: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="5.4"/>
                    <measurement group_id="O2" value="0.7" spread="5.1"/>
                    <measurement group_id="O3" value="1.1" spread="1.2"/>
                    <measurement group_id="O4" value="0.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.01</p_value>
            <p_value_desc>Statistical significance of the interaction term was based on a 2-sided alpha=0.01.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Binocular Computer Game Treatment Older Cohort</title>
          <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
        </group>
        <group group_id="E2">
          <title>Continued Spectacle Correction Older Cohort</title>
          <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
        </group>
        <group group_id="E3">
          <title>Binocular Computer Game Treatment Younger Cohort</title>
          <description>Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)&#xD;
iPad®: Binocular therapy using a Dig Rush application on an iPad®</description>
        </group>
        <group group_id="E4">
          <title>Continued Spectacle Correction Younger Cohort</title>
          <description>Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.&#xD;
Spectacle correction: Spectacle correction for all waking hours, 7 days per week</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center</name_or_title>
      <organization>Jaeb Center for Health Research</organization>
      <phone>813-975-8690</phone>
      <email>rkraker@jaeb.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02983552
org study id: ATS20
secondary id: 2U10EY011751
nct id: NCT02983552
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle
      correction with spectacle correction only, for treatment of amblyopia in children 4 to <13
      years of age.
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5
      days per week plus spectacle correction with spectacle correction only, for treatment of
      amblyopia in children 4 to <13 years of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
time frame: Baseline and 4 weeks
description: The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
measure: Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
time frame: 4 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
measure: Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort
time frame: Baseline and 8 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
measure: Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
time frame: 8 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
measure: Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort
time frame: baseline and 4 weeks
description: The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
measure: Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
time frame: 4 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
measure: Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort
time frame: Baseline and 8 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
measure: Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
time frame: 8 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
measure: VA Improvement at 4 Weeks Defined as a Binary Outcome
time frame: At 4 weeks
description: A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.
measure: VA Improvement at 8 Weeks Defined as a Binary Outcome
time frame: At 8 weeks
description: A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.
measure: Distribution of Stereoacuity Scores at 4 Weeks
time frame: 4 weeks
description: Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
measure: Distribution of Change in Stereoacuity Scores From Baseline
time frame: 4 weeks
description: Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
measure: Distribution of Stereoacuity Scores at 8 Weeks
time frame: 8 weeks
description: Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
measure: Distribution of Change in Stereoacuity Scores From Baseline
time frame: 8 weeks
description: Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.
measure: Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
time frame: 4 weeks
description: Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
measure: Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
time frame: 4 weeks
description: Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
measure: Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
time frame: 8 weeks
description: Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
measure: Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
time frame: 8 weeks
description: Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
measure: Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
time frame: 4 weeks
description: Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of >75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
measure: Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
time frame: 8 weeks
description: Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
measure: Treatment Compliance With Spectacle Wear
time frame: 4 weeks
description: Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed >75% of spectacle wear at 4 weeks.
measure: Treatment Compliance With Spectacle Wear
time frame: 8 weeks
description: Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed >75% of spectacle wear at 8 weeks.
measure: Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)
time frame: Baseline and 4 weeks
description: The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
measure: Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)
time frame: Baseline and 8 weeks
description: The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
measure: Ocular Alignment at 4 Weeks
time frame: 4 weeks
description: The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).
Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
measure: Ocular Alignment at 8 Weeks
time frame: 8 weeks
description: The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test.
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).
Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
measure: Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)
time frame: 4 weeks
description: The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
measure: Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)
time frame: 8 weeks
description: The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
measure: Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)
time frame: 4 weeks
description: A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
measure: Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)
time frame: 8 weeks
description: A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
measure: Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)
time frame: 4 weeks
description: The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
measure: Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)
time frame: 8 weeks
description: The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
measure: Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)
time frame: 4 weeks
description: A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
measure: Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)
time frame: 8 weeks
description: A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
measure: Frequency of Adverse Symptoms (Symptom Survey)
time frame: 4 weeks
description: The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
measure: Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks
time frame: 8 weeks
description: The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
measure: Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks
time frame: 4 weeks
description: The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
measure: Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks
time frame: 8 weeks
description: The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
measure: Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)
time frame: Baseline and 4 weeks
description: The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
measure: Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)
time frame: baseline and 8 weeks
description: The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
measure: Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks
time frame: Baseline and 4 weeks
description: The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted. Positive values for visual acuity change indicate improvement.
arm group label: Binocular Computer Game Treatment
arm group type: Experimental
description: Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)
arm group label: Continued Spectacle Correction
arm group type: Active Comparator
description: Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.
intervention type: Other
intervention name: iPad®
description: Binocular therapy using a Dig Rush application on an iPad®
arm group label: Binocular Computer Game Treatment
intervention type: Other
intervention name: Spectacle correction
description: Spectacle correction for all waking hours, 7 days per week
arm group label: Continued Spectacle Correction
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: No
last name: Ruth Manny, OD, PhD
role: Study Chair
affiliation: University of Houston College of Optometry
last name: Jonathan Holmes, MD
role: Study Chair
affiliation: Mayo Clinic
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country: Canada
country: United States
citation: Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22.
PMID: 30352226
responsible party type: Sponsor
mesh term: Amblyopia
sharing ipd: Yes
ipd description: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
ipd time frame: Data will be made available after publication of each primary manuscript.
ipd access criteria: Users accessing the data must enter an email address.
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