<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/NCT02200211</url>
  </required_header>
  <id_info>
    <org_study_id>ATS18</org_study_id>
    <secondary_id>2U10EY011751</secondary_id>
    <nct_id>NCT02200211</nct_id>
  </id_info>
  <brief_title>Study of Binocular Computer Activities for Treatment of Amblyopia</brief_title>
  <acronym>ATS18</acronym>
  <official_title>Study of Binocular Computer Activities for Treatment of 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play&#xD;
      7 days per week with 2 hours/day patching 7 days per week in children 5 to &lt;17&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to 1) compare the effectiveness of 1 hour/day of binocular game&#xD;
      play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week,&#xD;
      in children 5 to &lt;13 years of age (younger cohort), as a non-inferiority study; and 2) to&#xD;
      compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4&#xD;
      days per week) with 2 hours/day patching 7 days per week, in children 13 to &lt;17 years of age&#xD;
      (older cohort), as a superiority study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2014</start_date>
  <completion_date type="Actual">August 19, 2016</completion_date>
  <primary_completion_date type="Actual">August 19, 2016</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>Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to &lt;13 Years)</measure>
    <time_frame>Baseline and 16 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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Amblyopic Eye Visual Acuity (Younger Cohort)</measure>
    <time_frame>16 Weeks from baseline</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to &lt;17 Years)</measure>
    <time_frame>Baseline and 16 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 Amblyopic-eye Visual Acuity in the Older Cohort (13 to &lt;17 Years)</measure>
    <time_frame>16 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>Distribution of Change in Amblyopic-eye Visual Acuity</measure>
    <time_frame>Baseline and 16 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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution of Amblyopic-eye Visual Acuity</measure>
    <time_frame>At 16 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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline</measure>
    <time_frame>Baseline and 16-week visit</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Resolution of Amblyopia</measure>
    <time_frame>16-week visit</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.&#xD;
Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Course of Visual Acuity Improvement</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks and 16 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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups</measure>
    <time_frame>Baseline and 16 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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to &lt;7 yrs, 7 to &lt;13 yrs) and prior amblyopia treatment (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups</measure>
    <time_frame>Baseline and 16 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 (previously defined) 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;
Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Stereoacuity Scores</measure>
    <time_frame>16 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>Median Stereoacuity Score (Seconds of Arc)</measure>
    <time_frame>16 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. Lower scores indicate better stereoacuity.&#xD;
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.&#xD;
A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Stereoacuity Scores (Participants With no History of Strabismus)</measure>
    <time_frame>16 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</measure>
    <time_frame>Baseline and 16 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.&#xD;
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.&#xD;
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 16-week stereoacuity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)</measure>
    <time_frame>Baseline and 16 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.&#xD;
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.&#xD;
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 16-week stereoacuity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)</measure>
    <time_frame>Entire study period, up to 16 weeks</time_frame>
    <description>Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.&#xD;
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.&#xD;
The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).&#xD;
Post hoc analysis: 4-week fellow-eye contrast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)</measure>
    <time_frame>Entire study period, up to 16 weeks</time_frame>
    <description>Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.&#xD;
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.&#xD;
Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants Reporting &gt;75% of Prescribed Treatment Completed (Subjective Measures of Adherence)</measure>
    <time_frame>16 Weeks from baseline</time_frame>
    <description>Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.&#xD;
Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.&#xD;
At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participants Who Received Non-protocol, Alternative Treatment During the Study</measure>
    <time_frame>Entire study period, up to 16 weeks</time_frame>
    <description>Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.&#xD;
The number of participants who received non-protocol, alternative treatment was tabulated by treatment group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline</measure>
    <time_frame>16-week visit</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children &lt;7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Younger Cohort)</measure>
    <time_frame>16-week visit</time_frame>
    <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.&#xD;
For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Older Cohort)</measure>
    <time_frame>16-week visit</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.&#xD;
The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd</measure>
    <time_frame>16 weeks</time_frame>
    <description>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 16-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>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Parent-reported)</measure>
    <time_frame>16 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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Participant-reported)</measure>
    <time_frame>16 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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (Parent-reported)</measure>
    <time_frame>Across study follow-up visits, up to 16 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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (Participant-reported)</measure>
    <time_frame>Across study follow-up visits, up to 16 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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">485</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Binocular Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patching Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patching 2 hours per day, 7 days per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iPad®</intervention_name>
    <description>Binocular therapy on iPad®</description>
    <arm_group_label>Binocular Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patching 2 hours per day, 7 days per week</intervention_name>
    <arm_group_label>Patching Treatment</arm_group_label>
    <other_name>Patching</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 5 to &lt;17 years&#xD;
&#xD;
          2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or&#xD;
             untreated)&#xD;
&#xD;
               1. Criteria for strabismus: 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 spectacles)&#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;
                    -  ≥0.50 diopter (D) difference between eyes in spherical equivalent&#xD;
&#xD;
                    -  ≥1.50 D difference between eyes in astigmatism in any meridian&#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 between eyes in astigmatism in any meridian&#xD;
&#xD;
                    -  Note: the spherical equivalent requirement differs from that in the&#xD;
                       definition for refractive/anisometropic amblyopia&#xD;
&#xD;
          3. No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision&#xD;
             therapy)&#xD;
&#xD;
          4. Refractive correction (spectacles or contact lenses, if applicable) must meet the&#xD;
             following criteria at enrollment and be based on a cycloplegic refraction that is not&#xD;
             more than 7 months old.&#xD;
&#xD;
               1. Requirements for Correction of Refractive Error:&#xD;
&#xD;
                    1. For subjects meeting criteria for strabismic (only) amblyopia (see 2.2.1 #2&#xD;
                       above):&#xD;
&#xD;
                       • Hypermetropia, if corrected, must not be under-corrected by more than&#xD;
                       +1.50 D spherical equivalent, and the reduction in plus sphere must be&#xD;
                       symmetric in the two eyes.&#xD;
&#xD;
                    2. For subjects meeting criteria for anisometropic or combined-mechanism&#xD;
                       amblyopia (see 2.2.1 #2 above):&#xD;
&#xD;
                         -  Spherical equivalent must be within 0.50 D of fully correcting the&#xD;
                            anisometropia&#xD;
&#xD;
                         -  Hypermetropia must not be under-corrected by more than +1.50 D&#xD;
                            spherical equivalent, and reduction in plus must be symmetric in the&#xD;
                            two eyes&#xD;
&#xD;
                         -  Cylinder power in both eyes must be within 0.50 D of fully correcting&#xD;
                            the astigmatism&#xD;
&#xD;
                         -  Cylinder axis for both eyes must be within 6 degrees of the axis of the&#xD;
                            cycloplegic refraction when cylinder power is ≥1.00 D&#xD;
&#xD;
               2. Refractive corrections meeting the above criteria must be worn for either:&#xD;
&#xD;
                    -  16 weeks or more or&#xD;
&#xD;
                    -  Until visual acuity in amblyopic eye is stable (defined as 2 consecutive&#xD;
                       visual acuity measurements by the same testing method at least 4 weeks apart&#xD;
                       with &lt;1 line change (&lt;5 letters if E-ETDRS))&#xD;
&#xD;
               3. Monocular or binocular contact lens wear is allowed provided the contact lenses&#xD;
                  meet the above refractive requirements at the corneal plane. The same form of&#xD;
                  correction must be worn throughout the entire study during study procedures&#xD;
                  (i.e., no changing between contacts and spectacles while patching or while&#xD;
                  game-playing or study testing). Safety glasses are not required for subjects&#xD;
                  wearing contact lenses, but investigators are encouraged to suggest safety&#xD;
                  glasses be worn over contact lenses.&#xD;
&#xD;
          5. Visual acuity, measured in each eye without cycloplegia in current refractive&#xD;
             correction (if applicable) within 7 days prior to randomization using the Amblyopia&#xD;
             Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;&#xD;
             7 years and the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual&#xD;
             acuity protocol for children ≥ 7 years on a study-approved device displaying single&#xD;
             surrounded optotypes, as follows:&#xD;
&#xD;
               1. Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if&#xD;
                  E-ETDRS)&#xD;
&#xD;
               2. Visual acuity in the fellow eye 20/25 or better (≥ 78 letters if E-ETDRS)&#xD;
&#xD;
               3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters if E-ETDRS) (i.e.,&#xD;
                  amblyopic-eye acuity at least 3 logMAR lines worse than fellow-eye acuity)&#xD;
&#xD;
          6. Heterotropia or heterophoria with a total near deviation of ≤ 10∆ (measured by PACT).&#xD;
&#xD;
          7. Ability to align the nonius cross on the binocular game system (angles of ocular&#xD;
             deviation &gt;10∆ would require the nonius cross to be adjusted to such an extent that&#xD;
             playing of the game would be compromised).&#xD;
&#xD;
          8. Subject is able to play Hess Falling Blocks game on the study iPad® (on easy setting)&#xD;
             under binocular conditions (with red-green glasses), as demonstrated by scoring at&#xD;
             least 1 line in the office.&#xD;
&#xD;
          9. Investigator is willing to prescribe computer game play or patching per protocol.&#xD;
&#xD;
         10. Parent understands the protocol and is willing to accept randomization.&#xD;
&#xD;
         11. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center&#xD;
             staff.&#xD;
&#xD;
         12. Relocation outside of area of an active Pediatric Eye Disease Investigator Group&#xD;
             (PEDIG) site for this study within the next 16 weeks is not anticipated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A subject is excluded for any of the following reasons:&#xD;
&#xD;
          1. Prism in the refractive correction at time of enrollment (eligible only if prism is&#xD;
             discontinued 2 weeks prior to enrollment).&#xD;
&#xD;
          2. Myopia greater than -6.00 D spherical equivalent in either eye.&#xD;
&#xD;
          3. Previous intraocular or refractive surgery.&#xD;
&#xD;
          4. Any treatment for amblyopia (patching, atropine, Bangerter filter, or vision therapy)&#xD;
             during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but&#xD;
             must be discontinued at least 2 weeks immediately prior to enrollment.&#xD;
&#xD;
          5. Ocular co-morbidity that may reduce visual acuity determined by an ocular examination&#xD;
             performed within the past 7 months (Note: nystagmus per se does not exclude the&#xD;
             subject if the above visual acuity 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. Heterotropia or heterophoria with a total ocular deviation &gt;10∆ (phoria plus tropia&#xD;
             &gt;10∆) at near (measured by PACT).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Holmes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vivan Manh, OD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <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>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_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pedig.net</url>
    <description>PEDIG Public Website</description>
  </link>
  <results_reference>
    <citation>Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262.</citation>
    <PMID>27812703</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>March 1, 2018</results_first_submitted>
  <results_first_submitted_qc>September 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 15, 2018</results_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</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_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After primary manuscripts are published</ipd_time_frame>
    <ipd_access_criteria>Users accessing the data must enter an email address.</ipd_access_criteria>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Two separate sub-studies based on age at enrollment&#xD;
Younger Cohort defined as 5 to &lt;13 years of age Older Cohort defined as 13 to &lt;17 years of age</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Binocular Treatment Younger</title>
          <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
        </group>
        <group group_id="P2">
          <title>Patching Treatment Younger</title>
          <description>Patching 2 hours per day, 7 days per week</description>
        </group>
        <group group_id="P3">
          <title>Binocular Treatment Older</title>
          <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
        </group>
        <group group_id="P4">
          <title>Patching Treatment Older</title>
          <description>Patching 2 hours per day, 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="190"/>
                <participants group_id="P2" count="195"/>
                <participants group_id="P3" count="40"/>
                <participants group_id="P4" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Included in 16-week Primary Analysis</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="186"/>
                <participants group_id="P3" count="39"/>
                <participants group_id="P4" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="182"/>
                <participants group_id="P2" count="188"/>
                <participants group_id="P3" count="39"/>
                <participants group_id="P4" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Binocular Treatment Younger Cohort (5 to &lt;13 Years)</title>
          <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
        </group>
        <group group_id="B2">
          <title>Patching Treatment Younger Cohort (5 to &lt;13 Years)</title>
          <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
        </group>
        <group group_id="B3">
          <title>Binocular Treatment Older Cohort (13 to &lt;17 Years)</title>
          <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
        </group>
        <group group_id="B4">
          <title>Patching Treatment Older Cohort (13 to &lt;17 Years)</title>
          <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 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="190"/>
            <count group_id="B2" value="195"/>
            <count group_id="B3" value="40"/>
            <count group_id="B4" value="60"/>
            <count group_id="B5" value="485"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                    <measurement group_id="B2" value="195"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="60"/>
                    <measurement group_id="B5" value="485"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="1.8"/>
                    <measurement group_id="B2" value="8.6" spread="2.0"/>
                    <measurement group_id="B3" value="14.3" spread="1.1"/>
                    <measurement group_id="B4" value="14.3" spread="1.1"/>
                    <measurement group_id="B5" value="9.7" spread="2.9"/>
                  </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 at enrollment, years : 5 to &lt;7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at enrollment, years : 7 to &lt;9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at enrollment, years : 9 to &lt;13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at enrollment, years : 13 to &lt;17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="60"/>
                    <measurement group_id="B5" value="100"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="256"/>
                  </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>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="145"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian, American Indian, Alaskan Native</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;1 Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown/not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance Amblyopic-Eye Visual Acuity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>20/200 (33-37 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/160 (38-42 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/125 (43-47 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/100 (48-52 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/80 (53-57 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/63 (58-62 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/50 (63-67 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/40 (68-72 Letters)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Stereoacuity (Seconds of Arc)</title>
          <description>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.&#xD;
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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>4000</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2000</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>800</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>400</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline 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>
          <population>Descriptive statistics were computed for baseline stereoacuity by treatment group for all participants and a subset of participants with no history of strabismus.&#xD;
The younger (age 5 to &lt;7 years) and older (age 7 to &lt;13 years) were analyzed as separate study cohorts.&#xD;
Results of the descriptive analyses are reported as seconds of arc.</population>
          <units>Seconds of Arc</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>All participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2000" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B2" value="800" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B3" value="800" lower_limit="60" upper_limit="4000"/>
                    <measurement group_id="B4" value="2000" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B5" value="NA" lower_limit="40" upper_limit="4000">No overall median was calculated because the younger (age 5 to &lt;7 years) and older (age 7 to &lt;13 years) were analyzed as separate age cohorts in effectively separate studies.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with no history of strabismus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="107"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="22"/>
                    <count group_id="B4" value="29"/>
                    <count group_id="B5" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="400" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B2" value="400" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="B3" value="400" lower_limit="60" upper_limit="4000"/>
                    <measurement group_id="B4" value="800" lower_limit="60" upper_limit="4000"/>
                    <measurement group_id="B5" value="NA" lower_limit="40" upper_limit="4000">No overall median was calculated because the younger (age 5 to &lt;7 years) and older (age 7 to &lt;13 years) were analyzed as separate age cohorts in effectively separate studies.</measurement>
                  </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>
              <title>Strabismus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anisometropia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strabismus/anisometropia combined</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                    <count group_id="B2" value="195"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="60"/>
                    <count group_id="B5" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to &lt;13 Years)</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization), analysis is adjusted for baseline covariates of age and visual acuity.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to &lt;13 Years)</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.</description>
          <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization), analysis is adjusted for baseline covariates of age and visual acuity.</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="177"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjusted for baseline VA and age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" lower_limit="0.85" upper_limit="1.24"/>
                    <measurement group_id="O2" value="1.35" lower_limit="1.17" upper_limit="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="0.86" upper_limit="1.29"/>
                    <measurement group_id="O2" value="1.32" lower_limit="1.14" upper_limit="1.51"/>
                  </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 primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to &lt;20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.54</ci_upper_limit>
            <estimate_desc>A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to &lt;20 weeks after randomization).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.56</ci_upper_limit>
            <estimate_desc>A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.55</ci_upper_limit>
            <estimate_desc>A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to &lt;20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.58</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 16-week visit. Positive estimate values favor the patching treatment group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Amblyopic Eye Visual Acuity (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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.</description>
        <time_frame>16 Weeks from baseline</time_frame>
        <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Amblyopic Eye Visual Acuity (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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.</description>
          <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after 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="177"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.21"/>
                    <measurement group_id="O2" value="0.35" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to &lt;17 Years)</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 16 weeks</time_frame>
        <population>Mean change in amblyopic-eye visual acuity from baseline to 16 weeks from participants who completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Older</title>
            <description>Age 13 to &lt;17&#xD;
Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Older</title>
            <description>Age 13 to &lt;17&#xD;
Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to &lt;17 Years)</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>Mean change in amblyopic-eye visual acuity from baseline to 16 weeks from participants who completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)</population>
          <units>letters</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="39"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.3" upper_limit="5.7"/>
                    <measurement group_id="O2" value="6.5" lower_limit="4.4" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted for baseline visual acuity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="1.3" upper_limit="6.0"/>
                    <measurement group_id="O2" value="6.3" lower_limit="4.4" upper_limit="8.3"/>
                  </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>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 16 weeks (14 to &lt;20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.082</p_value>
            <p_value_desc>a priori threshold for statistical significance: 2-sided type I error rate of 5%</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Adjusted for baseline amblyopic-eye visual acuity.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.</estimate_desc>
          </analysis>
          <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 change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.9</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.</estimate_desc>
          </analysis>
          <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 change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to &lt;20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.9</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.0</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to &lt;20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to &lt;20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
            <estimate_desc>A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to &lt;17 Years)</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>16 weeks</time_frame>
        <population>Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Older</title>
            <description>Age 13 to &lt;17&#xD;
Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Older</title>
            <description>Age 13 to &lt;17&#xD;
Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to &lt;17 Years)</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>Participants that completed 16-week visit within pre-specified analysis window (148 to 196 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="39"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.0" spread="9.7"/>
                    <measurement group_id="O2" value="62.5" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Distribution of Change in Amblyopic-eye Visual Acuity</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Change in Amblyopic-eye Visual Acuity</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</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="177"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 3 LogMAR lines (≥ 15 letters) better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 LogMAR lines (10-14 letters) better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 LogMAR line (5-9 letters) better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 LogMAR line (within 4 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="69"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 LogMAR line (5-9 letters) worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 LogMAR lines (10-14 letters) worse</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>≥3 LogMAR lines (≥ 15 letters) worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <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_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Distribution of Amblyopic-eye Visual Acuity</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
        <time_frame>At 16 weeks</time_frame>
        <population>Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Amblyopic-eye Visual Acuity</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
          <population>Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)</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="177"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>20/200 (33-37 letters)</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/160 (38-42 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/125 (43-47 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/100 (48-52 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/80 (53-57 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/63 (58-62 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/50 (63-67 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/40 (68-72 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/32 (73-77 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/25 (78-82 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/20 (83-87 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20/16 (88-92 letters)</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_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
        <time_frame>Baseline and 16-week visit</time_frame>
        <population>Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to &lt;20 weeks after randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).&#xD;
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).</description>
          <population>Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to &lt;20 weeks after randomization).</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="177"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="17"/>
                  </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 16-week visit, adjusting for baseline age group (5 to &lt;7, 7 to &lt;13 years) and baseline visual acuity (treated as a continuous covariate).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4</ci_lower_limit>
            <ci_upper_limit>13</ci_upper_limit>
            <estimate_desc>Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</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 16-week visit, adjusting for baseline visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31</ci_lower_limit>
            <ci_upper_limit>2</ci_upper_limit>
            <estimate_desc>Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Resolution of Amblyopia</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.&#xD;
Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA.</description>
        <time_frame>16-week visit</time_frame>
        <population>Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to &lt;20 weeks after randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Resolution of Amblyopia</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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;
The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.&#xD;
Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA.</description>
          <population>Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to &lt;20 weeks after randomization).</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="177"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="18"/>
                    <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>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 16-week visit, adjusting for baseline age group (5 to &lt;7, 7 to &lt;13 years) and baseline visual acuity (20/40, 20/50 or worse).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Course of Visual Acuity Improvement</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks</time_frame>
        <population>Analysis included participants with at least one follow-up visit (completed within the analysis window). There were 6 participants (4 in the binocular group, 2 in the patching group) who were excluded from the time course analysis because they did not have any follow-up exams.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Time Course of Visual Acuity Improvement</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10.</description>
          <population>Analysis included participants with at least one follow-up visit (completed within the analysis window). There were 6 participants (4 in the binocular group, 2 in the patching group) who were excluded from the time course analysis because they did not have any follow-up exams.</population>
          <units>logMAR lines</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="186"/>
                <count group_id="O2" value="193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4-week visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="1.14"/>
                    <measurement group_id="O2" value="0.76" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-week visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="1.18"/>
                    <measurement group_id="O2" value="1.03" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-week visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="1.37"/>
                    <measurement group_id="O2" value="1.21" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16-week visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="1.45"/>
                    <measurement group_id="O2" value="1.32" spread="1.26"/>
                  </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 linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p&gt;0.05), no further comparisons would be performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.83</p_value>
            <p_value_desc>For testing the interaction term, the a priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Previously described above in the Statistical Analysis Overview section.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to &lt;7 yrs, 7 to &lt;13 yrs) and prior amblyopia treatment (yes/no).</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization). Formal subgroup analyses are adjusted for baseline covariates of visual acuity and age.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to &lt;7 yrs, 7 to &lt;13 yrs) and prior amblyopia treatment (yes/no).</description>
          <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization). Formal subgroup analyses are adjusted for baseline covariates of visual acuity and age.</population>
          <units>LogMAR lines</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.5"/>
                    <measurement group_id="O2" value="1.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.4"/>
                    <measurement group_id="O2" value="1.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Non-Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.5"/>
                    <measurement group_id="O2" value="1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-White or Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.5"/>
                    <measurement group_id="O2" value="1.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at baseline: 5 to &lt;7 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.8"/>
                    <measurement group_id="O2" value="2.0" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at baseline: 7 to &lt;13 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.2"/>
                    <measurement group_id="O2" value="1.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/80 to 20/200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.6"/>
                    <measurement group_id="O2" value="1.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/63</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.6"/>
                    <measurement group_id="O2" value="1.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.3"/>
                    <measurement group_id="O2" value="1.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.2"/>
                    <measurement group_id="O2" value="1.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline stereoacuity: Nil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.3"/>
                    <measurement group_id="O2" value="1.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline stereoacuity: Better than Nil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.5"/>
                    <measurement group_id="O2" value="1.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No presence of a near heterotropia at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.3"/>
                    <measurement group_id="O2" value="1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presence of a near heterotropia at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.7"/>
                    <measurement group_id="O2" value="1.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No prior amblyopia treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.5"/>
                    <measurement group_id="O2" value="2.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior amblyopia treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.4"/>
                    <measurement group_id="O2" value="1.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Age 5 to &lt;7 yrs, no prior treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.5"/>
                    <measurement group_id="O2" value="2.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Age 5 to &lt;7 yrs, prior treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.9"/>
                    <measurement group_id="O2" value="1.4" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Age 7 to &lt;13 yrs, no prior treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.2"/>
                    <measurement group_id="O2" value="1.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Age 7 to &lt;13 yrs, prior treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.2"/>
                    <measurement group_id="O2" value="1.0" spread="1.1"/>
                  </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>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.83</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Previously described in the Statistical Analysis Overview.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.54</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.99</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.87</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.33</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.23</p_value>
            <p_value_desc>The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups</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 (previously defined) 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;
Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil).</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups</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 (previously defined) 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;
Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil).</description>
          <population>Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks 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="39"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="6.8"/>
                    <measurement group_id="O2" value="6.0" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="6.4"/>
                    <measurement group_id="O2" value="6.8" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="7.1"/>
                    <measurement group_id="O2" value="6.4" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-White or Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="6.1"/>
                    <measurement group_id="O2" value="6.7" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/80 to 20/200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="7.8"/>
                    <measurement group_id="O2" value="7.1" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/63</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="2.8"/>
                    <measurement group_id="O2" value="5.0" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="4.2"/>
                    <measurement group_id="O2" value="6.0" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline amblyopic-eye VA: 20/40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="10.9"/>
                    <measurement group_id="O2" value="6.8" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No prior amblyopia treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="6.4"/>
                    <measurement group_id="O2" value="10.3" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior amblyopia treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="7.0"/>
                    <measurement group_id="O2" value="6.0" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline stereoacuity: Nil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="7.7"/>
                    <measurement group_id="O2" value="5.7" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline stereoacuity: Better than Nil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="6.2"/>
                    <measurement group_id="O2" value="7.2" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No presence of a near heterotropia at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="6.1"/>
                    <measurement group_id="O2" value="5.6" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presence of a near heterotropia at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="7.4"/>
                    <measurement group_id="O2" value="7.9" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Stereoacuity Scores</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>16 weeks</time_frame>
        <population>The analysis included all participants who completed a 16-week exam regardless of whether or not the exam was completed within the pre-specified analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Stereoacuity Scores</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>The analysis included all participants who completed a 16-week exam regardless of whether or not the exam was 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="182"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Missing/Not done</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>4000 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2000 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>800 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>400 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>200 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Stereoacuity Score (Seconds of Arc)</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. Lower scores indicate better stereoacuity.&#xD;
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.&#xD;
A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc.</description>
        <time_frame>16 weeks</time_frame>
        <population>Participants who completed stereoacuity testing at the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).&#xD;
Descriptive analyses were repeated for a subset of participants with no history of strabismus.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Median Stereoacuity Score (Seconds of Arc)</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. Lower scores indicate better stereoacuity.&#xD;
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.&#xD;
A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc.</description>
          <population>Participants who completed stereoacuity testing at the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).&#xD;
Descriptive analyses were repeated for a subset of participants with no history of strabismus.</population>
          <units>Seconds of arc</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="181"/>
                    <count group_id="O2" value="188"/>
                    <count group_id="O3" value="39"/>
                    <count group_id="O4" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2000" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="O2" value="800" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="O3" value="800" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="O4" value="2000" lower_limit="40" upper_limit="4000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with no history of strabismus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="O2" value="400" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="O3" value="400" lower_limit="40" upper_limit="4000"/>
                    <measurement group_id="O4" value="2000" lower_limit="40" upper_limit="4000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </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>16 weeks</time_frame>
        <population>The analysis was limited to a subset of participants (no history of strabismus) who completed a 16-week exam regardless of whether or not the exam was completed within the pre-specified analysis window.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 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>The analysis was limited to a subset of participants (no history of strabismus) who completed a 16-week exam regardless of whether or not the exam was 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="105"/>
                <count group_id="O2" value="90"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Missing/Not done</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>4000 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2000 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>800 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>400 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>200 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 seconds of arc</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <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.&#xD;
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.&#xD;
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 16-week stereoacuity scores.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>The analysis included all participants who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was completed within the pre-specified analysis window).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 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.&#xD;
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.&#xD;
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 16-week stereoacuity scores.</description>
          <population>The analysis included all participants who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was 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="181"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </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="19"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1 level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="122"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 or more levels better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="12"/>
                  </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 Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.83</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </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.&#xD;
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.&#xD;
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 16-week stereoacuity scores.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>The analysis included a subset of participants with no history of strabismus who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was completed within the pre-specified analysis window).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 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.&#xD;
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.&#xD;
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 16-week stereoacuity scores.</description>
          <population>The analysis included a subset of participants with no history of strabismus who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was 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="104"/>
                <count group_id="O2" value="90"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="27"/>
              </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="12"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="2"/>
                    <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="67"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 or more levels better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="4"/>
                    <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>The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.69</p_value>
            <p_value_desc>A priori threshold for statistical significance was 0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)</title>
        <description>Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.&#xD;
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.&#xD;
The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).&#xD;
Post hoc analysis: 4-week fellow-eye contrast.</description>
        <time_frame>Entire study period, up to 16 weeks</time_frame>
        <population>The descriptive analysis included data from participants in the binocular treatment group who had log file data available.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)</title>
          <description>Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.&#xD;
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.&#xD;
The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).&#xD;
Post hoc analysis: 4-week fellow-eye contrast.</description>
          <population>The descriptive analysis included data from participants in the binocular treatment group who had log file data available.</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="176"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completed &gt;75% prescribed game play</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 100% (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 20% or worse (16 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow-eye contrast of 100% (4 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)</title>
        <description>Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.&#xD;
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.&#xD;
Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.</description>
        <time_frame>Entire study period, up to 16 weeks</time_frame>
        <population>The descriptive analysis included data from participants in the binocular treatment group who had log file data available.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)</title>
          <description>Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.&#xD;
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.&#xD;
Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.</description>
          <population>The descriptive analysis included data from participants in the binocular treatment group who had log file data available.</population>
          <units>% of prescribed treatment completed</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="20" upper_limit="72"/>
                    <measurement group_id="O2" value="21" lower_limit="13" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants Reporting &gt;75% of Prescribed Treatment Completed (Subjective Measures of Adherence)</title>
        <description>Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.&#xD;
Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.&#xD;
At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline.</description>
        <time_frame>16 Weeks from baseline</time_frame>
        <population>The descriptive analysis included data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting &gt;75% of Prescribed Treatment Completed (Subjective Measures of Adherence)</title>
          <description>Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.&#xD;
Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.&#xD;
At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline.</description>
          <population>The descriptive analysis included data from participants who completed the 16-week visit within the predefined analysis window (14 to &lt;20 weeks after randomization).</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="177"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="172"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Participants Who Received Non-protocol, Alternative Treatment During the Study</title>
        <description>Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.&#xD;
The number of participants who received non-protocol, alternative treatment was tabulated by treatment group.</description>
        <time_frame>Entire study period, up to 16 weeks</time_frame>
        <population>All randomized participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Received Non-protocol, Alternative Treatment During the Study</title>
          <description>Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.&#xD;
The number of participants who received non-protocol, alternative treatment was tabulated by treatment group.</description>
          <population>All randomized participants in the study.</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="190"/>
                <count group_id="O2" value="195"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <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>Other Pre-specified</type>
        <title>Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline</title>
        <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children &lt;7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.</description>
        <time_frame>16-week visit</time_frame>
        <population>Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline</title>
          <description>Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children &lt;7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.</description>
          <population>Participants who completed the 16-week visit (regardless of whether or not the visit was 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="182"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 lines (10-14 letters) better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 line (5-9 letters) better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 line (within 4 letters)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="133"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 line (5-9 letters) worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 lines (10-14 letters) worse</title>
              <category_list>
                <category>
                  <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_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.&#xD;
For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity.</description>
        <time_frame>16-week visit</time_frame>
        <population>Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (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 Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children &lt;7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.&#xD;
For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity.</description>
          <population>Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).</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="182"/>
                <count group_id="O2" value="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="0.20" upper_limit="0.40"/>
                    <measurement group_id="O2" value="0.14" lower_limit="0.04" upper_limit="0.24"/>
                  </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 treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
            <estimate_desc>A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (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.&#xD;
The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity.</description>
        <time_frame>16-week visit</time_frame>
        <population>Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (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.&#xD;
The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity.</description>
          <population>Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).</population>
          <units>Letters</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="39"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.2" upper_limit="3.1"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.3" upper_limit="2.8"/>
                  </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>
            <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 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% 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>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
            <estimate_desc>A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd</title>
        <description>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 16-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>16 weeks</time_frame>
        <population>Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd</title>
          <description>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 16-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>Participants who completed the 16-week visit (regardless of whether or not the visit was 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="182"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="3"/>
                    <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>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 16-week visit.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.32</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</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 16-week visit.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety Analysis: Distribution of Diplopia Frequency at 16 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.</description>
        <time_frame>16 weeks</time_frame>
        <population>Participants whose parent completed a 16-week diplopia assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Distribution of Diplopia Frequency at 16 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.</description>
          <population>Participants whose parent completed a 16-week diplopia assessment.</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="182"/>
                <count group_id="O2" value="187"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No diplopia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176"/>
                    <measurement group_id="O2" value="185"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <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>Diplopia: Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: 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>Diplopia: 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>Diplopia: &gt;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 Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <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>0.48</p_value>
            <method>Cochran-Armitage trend test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</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>Other Pre-specified</type>
        <title>Safety Analysis: Distribution of Diplopia Frequency at 16 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.</description>
        <time_frame>16 weeks</time_frame>
        <population>Participants who completed a 16-week diplopia assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Distribution of Diplopia Frequency at 16 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.</description>
          <population>Participants who completed a 16-week diplopia assessment.</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="182"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No diplopia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="181"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: 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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Up to 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <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>
              <title>Diplopia: &gt;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="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>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <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>0.02</p_value>
            <method>Cochran-Armitage trend test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.99</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</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>Other Pre-specified</type>
        <title>Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (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.</description>
        <time_frame>Across study follow-up visits, up to 16 weeks</time_frame>
        <population>Participants whose parent completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week)</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (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.</description>
          <population>Participants whose parent completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week)</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="182"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No diplopia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                    <measurement group_id="O2" value="182"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Once a week</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Once 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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Up to 10 times 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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: &gt;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>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (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.</description>
        <time_frame>Across study follow-up visits, up to 16 weeks</time_frame>
        <population>Participants who completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week) during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Binocular Treatment Younger</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O2">
            <title>Patching Treatment Younger</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
          <group group_id="O3">
            <title>Binocular Treatment Older Cohort</title>
            <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
          </group>
          <group group_id="O4">
            <title>Patching Treatment Older Cohort</title>
            <description>Patching 2 hours per day, 7 days per week</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (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.</description>
          <population>Participants who completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week) during the study.</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="182"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No diplopia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                    <measurement group_id="O2" value="167"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Less than once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Once a week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Once a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: Up to 10 times a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diplopia: &gt;10 times a day</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>All the time</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_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Binocular Treatment Younger</title>
          <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
        </group>
        <group group_id="E2">
          <title>Patching Treatment Younger</title>
          <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
        </group>
        <group group_id="E3">
          <title>Binocular Treatment Older</title>
          <description>Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)&#xD;
iPad®: Binocular therapy on iPad®</description>
        </group>
        <group group_id="E4">
          <title>Patching Treatment Older</title>
          <description>Patching 2 hours per day, 7 days per week&#xD;
Patching 2 hours per day, 7 days per week</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="190"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="60"/>
              </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="190"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="60"/>
              </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/NCT02200211
org study id: ATS18
secondary id: 2U10EY011751
nct id: NCT02200211
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play
      7 days per week with 2 hours/day patching 7 days per week in children 5 to <17
The purpose of the study is to 1) compare the effectiveness of 1 hour/day of binocular game
      play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week,
      in children 5 to <13 years of age (younger cohort), as a non-inferiority study; and 2) to
      compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4
      days per week) with 2 hours/day patching 7 days per week, in children 13 to <17 years of age
      (older cohort), as a superiority study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years)
time frame: Baseline and 16 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.
measure: Mean Amblyopic Eye Visual Acuity (Younger Cohort)
time frame: 16 Weeks from baseline
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.
measure: Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)
time frame: Baseline and 16 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 Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)
time frame: 16 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: Distribution of Change in Amblyopic-eye Visual Acuity
time frame: Baseline and 16 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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.
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).
measure: Distribution of Amblyopic-eye Visual Acuity
time frame: At 16 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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.
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).
measure: Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline
time frame: Baseline and 16-week visit
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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.
Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).
Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).
measure: Number of Participants With Resolution of Amblyopia
time frame: 16-week visit
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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.
The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.
Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA.
measure: Time Course of Visual Acuity Improvement
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10.
measure: Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
time frame: Baseline and 16 weeks
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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 younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to <7 yrs, 7 to <13 yrs) and prior amblyopia treatment (yes/no).
measure: Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups
time frame: Baseline and 16 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 (previously defined) 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.
Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil).
measure: Distribution of Stereoacuity Scores
time frame: 16 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: Median Stereoacuity Score (Seconds of Arc)
time frame: 16 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.
A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc.
measure: Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
time frame: 16 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
time frame: Baseline and 16 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 16-week stereoacuity scores.
measure: Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
time frame: Baseline and 16 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 16-week stereoacuity scores.
measure: Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)
time frame: Entire study period, up to 16 weeks
description: Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.
The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).
Post hoc analysis: 4-week fellow-eye contrast.
measure: Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)
time frame: Entire study period, up to 16 weeks
description: Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.
The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.
Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.
measure: Percentage of Participants Reporting >75% of Prescribed Treatment Completed (Subjective Measures of Adherence)
time frame: 16 Weeks from baseline
description: Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.
Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.
At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline.
measure: Participants Who Received Non-protocol, Alternative Treatment During the Study
time frame: Entire study period, up to 16 weeks
description: Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.
The number of participants who received non-protocol, alternative treatment was tabulated by treatment group.
measure: Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline
time frame: 16-week visit
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children <7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.
measure: Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Younger Cohort)
time frame: 16-week visit
description: Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and 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 younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.
For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity.
measure: Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Older Cohort)
time frame: 16-week visit
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.
The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity.
measure: Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd
time frame: 16 weeks
description: 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 16-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: Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Parent-reported)
time frame: 16 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.
measure: Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Participant-reported)
time frame: 16 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.
measure: Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (Parent-reported)
time frame: Across study follow-up visits, up to 16 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.
measure: Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (Participant-reported)
time frame: Across study follow-up visits, up to 16 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.
arm group label: Binocular Treatment
arm group type: Experimental
description: Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)
arm group label: Patching Treatment
arm group type: Active Comparator
description: Patching 2 hours per day, 7 days per week
intervention type: Device
intervention name: iPad®
description: Binocular therapy on iPad®
arm group label: Binocular Treatment
intervention type: Other
intervention name: Patching 2 hours per day, 7 days per week
arm group label: Patching Treatment
other name: Patching
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Jonathan Holmes, MD
role: Study Chair
affiliation: Mayo Clinic
last name: Vivan Manh, OD
role: Study Chair
affiliation: University of Washington
facility: 
facility: 
country: United States
url: http://www.pedig.net
description: PEDIG Public Website
citation: Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262.
PMID: 27812703
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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: After primary manuscripts are published
ipd access criteria: Users accessing the data must enter an email address.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 