<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/NCT02223650</url>
  </required_header>
  <id_info>
    <org_study_id>IXT3</org_study_id>
    <secondary_id>2U10EY011751</secondary_id>
    <nct_id>NCT02223650</nct_id>
  </id_info>
  <brief_title>A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia</brief_title>
  <acronym>IXT3</acronym>
  <official_title>A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia</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 objective of this short-term, pilot randomized trial comparing 2.50 diopters (D)&#xD;
      overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in&#xD;
      children with intermittent exotropia (IXT) 3 to &lt;7 years of age is to determine whether to&#xD;
      proceed to a full-scale, longer-term randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens&#xD;
      treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine&#xD;
      whether to proceed to a full-scale, longer-term randomized trial. This decision will be based&#xD;
      primarily on assessing the initial (8-week) response to overminus by comparing treatment&#xD;
      groups on the following outcomes:&#xD;
&#xD;
        -  Mean distance IXT control score (each patient's score is the mean of 3 control scores)&#xD;
           (primary outcome)&#xD;
&#xD;
        -  The proportion of subjects with treatment response, defined as 1 or more points&#xD;
           improvement in mean of 3 distance IXT control scores (secondary outcome)&#xD;
&#xD;
        -  Adverse effects, near visual acuity outcomes, and spectacle wear compliance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Distance Exotropia Control Score</measure>
    <time_frame>8 weeks</time_frame>
    <description>At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a &quot;triple control score,&quot; which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.&#xD;
*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Near Exotropia Control Score</measure>
    <time_frame>8 weeks</time_frame>
    <description>At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a &quot;triple control score,&quot; which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Distance Control Score at 8-week Outcome</measure>
    <time_frame>8 weeks</time_frame>
    <description>Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Near Control Score at 8-week Outcome</measure>
    <time_frame>8 weeks</time_frame>
    <description>Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Distance Control Treatment Response</measure>
    <time_frame>8 weeks</time_frame>
    <description>A comparison of the proportion of subjects showing a &quot;treatment response,&quot; defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?</measure>
    <time_frame>8 weeks</time_frame>
    <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stereoacuity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Visual Acuity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binocular Near Visual Acuity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?</measure>
    <time_frame>8 weeks</time_frame>
    <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?</measure>
    <time_frame>8 weeks</time_frame>
    <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?</measure>
    <time_frame>8 weeks</time_frame>
    <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Near Control Treatment Response</measure>
    <time_frame>8 weeks</time_frame>
    <description>A comparison of the proportion of subjects showing a &quot;treatment response,&quot; defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Intermittent Exotropia</condition>
  <arm_group>
    <arm_group_label>Overminus Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.50D overminus spectacles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-overminus Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>spectacles without overminus or no spectacles</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Overminus treatment</intervention_name>
    <description>2.50D overminus spectacles</description>
    <arm_group_label>Overminus Treatment</arm_group_label>
    <other_name>Overminus spectacles</other_name>
    <other_name>Overminus glasses</other_name>
    <other_name>Overminus therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-overminus treatment</intervention_name>
    <description>spectacles without overminus or no spectacles</description>
    <arm_group_label>Non-overminus Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The following criteria must be met for the child to be enrolled in the study:&#xD;
&#xD;
          -  Age 3 years to &lt; 7 years&#xD;
&#xD;
          -  Intermittent exotropia (manifest deviation) meeting all of the following criteria:&#xD;
&#xD;
               -  Intermittent exotropia or constant exotropia at distance&#xD;
&#xD;
                    -  Mean distance control score of 2 points or more (mean of 3 assessments over&#xD;
                       the exam)&#xD;
&#xD;
               -  Intermittent exotropia, exophoria, or orthophoria at near&#xD;
&#xD;
                    -  Subject cannot have a score of 5 points on all 3 near assessments of control&#xD;
&#xD;
               -  Exodeviation at least 15∆ at distance measured by PACT&#xD;
&#xD;
               -  Near deviation does not exceed distance deviation by more than 10∆ by PACT&#xD;
                  (convergence insufficiency type IXT excluded)&#xD;
&#xD;
          -  No previous non-surgical treatment for IXT (other than refractive correction),&#xD;
             including vision therapy for IXT, within the past 6 months.&#xD;
&#xD;
          -  No previous substantial overminus treatment, defined as wearing spectacles that are&#xD;
             overminused by 1.00D SE or more (treatment with lenses overminused by less than 1.00D&#xD;
             SE is allowed at any time prior to enrollment).&#xD;
&#xD;
          -  No vision therapy, patching, atropine, or other penalization for amblyopia during the&#xD;
             last 2 weeks&#xD;
&#xD;
          -  No prior strabismus, intraocular, or refractive surgery (including BOTOX injection)&#xD;
&#xD;
          -  Cycloplegic refraction within 7 months, but NOT on the day of enrollment&#xD;
&#xD;
          -  Spherical equivalent (SE) in both eyes between -6.00D and +1.00D inclusive&#xD;
&#xD;
          -  Distance visual acuity 0.3 logMAR (20/40) or better (by ATS-HOTV) in both eyes&#xD;
&#xD;
          -  No interocular difference of distance visual acuity more than 0.2 logMAR (2 lines)&#xD;
&#xD;
          -  Child must be wearing refractive correction (pre-study spectacles) for at least 1 week&#xD;
             if refractive error (based on cycloplegic refraction performed within 7 months) meets&#xD;
             any of the following:&#xD;
&#xD;
               -  SE anisometropia ≥1.00 D&#xD;
&#xD;
               -  Astigmatism ≥1.00 D in either eye&#xD;
&#xD;
               -  SE myopia ≥-0.50 D in either eye&#xD;
&#xD;
          -  Refractive correction must meet the following criteria relative to the cycloplegic&#xD;
             refraction:&#xD;
&#xD;
               -  SE anisometropia must be within &lt;1.0D of the SE anisometropic difference&#xD;
&#xD;
               -  Astigmatism must be within &lt;1.00D of full magnitude; axis must be within 10&#xD;
                  degrees if ≤1.00D, and within 5 degrees if &gt;1.00D.&#xD;
&#xD;
               -  The SE of the spectacles must be within &lt;1.00D of the full cycloplegic refraction&#xD;
                  SE.&#xD;
&#xD;
                    -  A correction that yields at least 1.00 D more minus SE than the cycloplegic&#xD;
                       refraction SE is considered previous substantial overminus lens treatment&#xD;
                       and the patient is not eligible.&#xD;
&#xD;
          -  No current contact lens wear&#xD;
&#xD;
          -  No abnormality of the cornea, lens, or central retina&#xD;
&#xD;
          -  Gestational age ≥ 32 weeks&#xD;
&#xD;
          -  Birth weight &gt; 1500 grams&#xD;
&#xD;
          -  No Down syndrome or cerebral palsy&#xD;
&#xD;
          -  No severe developmental delay which would interfere with treatment or evaluation (in&#xD;
             the opinion of the investigator). Subjects with mild speech delays or reading and/or&#xD;
             learning disabilities are not excluded.&#xD;
&#xD;
          -  No disease known to affect accommodation, vergence, and ocular motility such as&#xD;
             multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or&#xD;
             Parkinson disease&#xD;
&#xD;
          -  No current use of any ocular or systemic medication known to affect accommodation or&#xD;
             vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic&#xD;
             agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch&#xD;
             (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine,&#xD;
             chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic&#xD;
             antidepressants (e.g., Elavil, Nortriptyline, Tofranil)&#xD;
&#xD;
          -  Parent understands the protocol and is willing to accept randomization to overminus&#xD;
             spectacles or non-overminus status&#xD;
&#xD;
          -  Parent has home phone (or access to phone) and is willing to be contacted by Jaeb&#xD;
             Center staff and Investigator's site staff&#xD;
&#xD;
          -  Relocation outside of area of an active PEDIG site within next 8 weeks is not&#xD;
             anticipated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan M Holmes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela M Chen, OD, MS</last_name>
    <role>Study Chair</role>
    <affiliation>Marshall B. Ketchum University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marshall B. Ketchum University</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92831</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://pedig.jaeb.org</url>
    <description>PEDIG Public Website</description>
  </link>
  <results_reference>
    <citation>Pediatric Eye Disease Investigator Group; Chen AM, Holmes JM, Chandler DL, Patel RA, Gray ME, Erzurum SA, Wallace DK, Kraker RT, Jensen AA. A Randomized Trial Evaluating Short-term Effectiveness of Overminus Lenses in Children 3 to 6 Years of Age with Intermittent Exotropia. Ophthalmology. 2016 Oct;123(10):2127-36. doi: 10.1016/j.ophtha.2016.06.042. Epub 2016 Aug 6.</citation>
    <PMID>27506485</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>August 30, 2016</results_first_submitted>
  <results_first_submitted_qc>October 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 20, 2016</results_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intermittent Exotropia</keyword>
  <keyword>IXT</keyword>
  <keyword>overminus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exotropia</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>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Between December 2014 and May 2015, 58 children were enrolled at 21 sites, with 31 participants assigned to observation and 27 to overminus treatment.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Overminus Treatment</title>
          <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
        </group>
        <group group_id="P2">
          <title>Non-overminus Treatment</title>
          <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overminus Treatment</title>
          <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
        </group>
        <group group_id="B2">
          <title>Non-overminus Treatment</title>
          <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
        </group>
        <group group_id="B3">
          <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="27"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="1"/>
                    <measurement group_id="B2" value="5.1" spread="1.2"/>
                    <measurement group_id="B3" value="5.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <description>Baseline age reflects age at randomization. The age eligibility requirement at enrollment was 3 to &lt;7 years old.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>3 to &lt;4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to &lt;5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 to &lt;6 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 to &lt;7 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Refractive error in more myopic eye (spherical equivalent, D)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&gt;+0.50 to +1.00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 to +0.50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;0 to &gt;-0.50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-0.50 to &gt;-1.00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1.00 to &gt;-1.50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1.50 to &gt;-2.00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-2.00 to &gt;-2.50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-2.50 to &gt;-3.00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=-3.00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Accommodative convergence over accommodation (AC/A) ratio</title>
          <description>Accommodative convergence over accommodation (AC/A) ratio calculated by taking the difference between the distance (6m) Prism Alternate Cover Test measurements with the participant wearing habitual correction and with the participant wearing -2.00D lenses over the habitual correction, and dividing the difference by 2.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;2.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.5 to 6.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;6.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Distance Exotropia Control Score</title>
        <description>At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a &quot;triple control score,&quot; which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.&#xD;
*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Distance Exotropia Control Score</title>
          <description>At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a &quot;triple control score,&quot; which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.&#xD;
*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.</description>
          <units>points on control score scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.4"/>
                    <measurement group_id="O2" value="2.8" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.01</p_value>
            <p_value_desc>P-value is calculated for one-sided hypothesis test.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.42</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
            <estimate_desc>Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Near Exotropia Control Score</title>
        <description>At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a &quot;triple control score,&quot; which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Near Exotropia Control Score</title>
          <description>At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a &quot;triple control score,&quot; which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.</description>
          <units>points on control score scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.2"/>
                    <measurement group_id="O2" value="1.2" 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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.14</p_value>
            <p_value_desc>P-value is calculated for one-sided hypothesis test.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>0.19</ci_upper_limit>
            <estimate_desc>Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Distance Control Score at 8-week Outcome</title>
        <description>Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Distance Control Score at 8-week Outcome</title>
          <description>Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 to &lt;1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 to &lt;2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 to &lt;3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 to &lt;4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Near Control Score at 8-week Outcome</title>
        <description>Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Near Control Score at 8-week Outcome</title>
          <description>Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 to &lt;1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 to &lt;2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 to &lt;3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 to &lt;4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Distance Control Treatment Response</title>
        <description>A comparison of the proportion of subjects showing a &quot;treatment response,&quot; defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Distance Control Treatment Response</title>
          <description>A comparison of the proportion of subjects showing a &quot;treatment response,&quot; defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" 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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.07</p_value>
            <p_value_desc>The p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6</ci_lower_limit>
            <ci_upper_limit>45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?</title>
        <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
        <time_frame>8 weeks</time_frame>
        <population>Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).</population>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>Spectacle-related questions at follow up apply to all overminus group participants.</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?</title>
          <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
          <population>Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Looked over specatcles: Always</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Looked over specatcles: Often</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Looked over specatcles: Sometimes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Looked over specatcles: Rarely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Looked over specatcles: Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stereoacuity</title>
        <description>Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Stereoacuity</title>
          <description>Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.</description>
          <units>log arcsecond</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.5"/>
                    <measurement group_id="O2" value="2.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distance Visual Acuity</title>
        <description>Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Visual Acuity</title>
          <description>Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance</description>
          <units>prism diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" spread="11.2"/>
                    <measurement group_id="O2" value="23.0" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Near Visual Acuity</title>
        <description>Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Near Visual Acuity</title>
          <description>Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.</description>
          <units>prism diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="8.3"/>
                    <measurement group_id="O2" value="16.9" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?</title>
        <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>Spectacle-related questions at follow up apply to all overminus group participants.</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?</title>
          <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Always</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Often</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sometimes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rarely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?</title>
        <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
        <time_frame>8 weeks</time_frame>
        <population>Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).</population>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?</title>
          <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
          <population>Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Always</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Often</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sometimes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rarely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?</title>
        <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?</title>
          <description>A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Always</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Often</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sometimes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rarely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Near Control Treatment Response</title>
        <description>A comparison of the proportion of subjects showing a &quot;treatment response,&quot; defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overminus Treatment</title>
            <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
          </group>
          <group group_id="O2">
            <title>Non-overminus Treatment</title>
            <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Near Control Treatment Response</title>
          <description>A comparison of the proportion of subjects showing a &quot;treatment response,&quot; defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.54</p_value>
            <p_value_desc>The p-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.001</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23</ci_lower_limit>
            <ci_upper_limit>24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 8 weeks after randomization.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Overminus Treatment</title>
          <description>2.50D overminus spectacles&#xD;
Overminus treatment: 2.50D overminus spectacles</description>
        </group>
        <group group_id="E2">
          <title>Non-overminus Treatment</title>
          <description>spectacles without overminus or no spectacles&#xD;
Non-overminus treatment: spectacles without overminus or no spectacles</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Development of esodeviation</sub_title>
                <description>One participant had near deviation change from 12 PD exodeviation at baseline to 3 PD esodeviation at 8 weeks. During same period, exodeviation at distance changed from 20 PD to 12 PD and stereoacuity at near changed from 100 arcsec to 60 arcsec.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Reduction in monocular distance visual acuity &gt;=2 lines</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Reduction in binocular near visual acuity &gt;=2 lines</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </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>
    <limitations_and_caveats>Small sample size; only 8-weeks of follow up; high test-retest variability of control; some regression to the mean may be present; do not know if treatment effect would persist after overminus lenses are replaced with usual spectacle correction.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ray 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/NCT02223650
org study id: IXT3
secondary id: 2U10EY011751
nct id: NCT02223650
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D)
      overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in
      children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to
      proceed to a full-scale, longer-term randomized trial.
The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens
      treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine
      whether to proceed to a full-scale, longer-term randomized trial. This decision will be based
      primarily on assessing the initial (8-week) response to overminus by comparing treatment
      groups on the following outcomes:

        -  Mean distance IXT control score (each patient's score is the mean of 3 control scores)
           (primary outcome)

        -  The proportion of subjects with treatment response, defined as 1 or more points
           improvement in mean of 3 distance IXT control scores (secondary outcome)

        -  Adverse effects, near visual acuity outcomes, and spectacle wear compliance
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Distance Exotropia Control Score
time frame: 8 weeks
description: At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.
*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.
measure: Mean Near Exotropia Control Score
time frame: 8 weeks
description: At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.
measure: Distribution of Distance Control Score at 8-week Outcome
time frame: 8 weeks
description: Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
measure: Distribution of Near Control Score at 8-week Outcome
time frame: 8 weeks
description: Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
measure: Proportion of Subjects With Distance Control Treatment Response
time frame: 8 weeks
description: A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
measure: Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
time frame: 8 weeks
description: A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
measure: Stereoacuity
time frame: 8 weeks
description: Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.
measure: Distance Visual Acuity
time frame: 8 weeks
description: Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance
measure: Binocular Near Visual Acuity
time frame: 8 weeks
description: Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.
measure: Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
time frame: 8 weeks
description: A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
measure: Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
time frame: 8 weeks
description: A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
measure: Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
time frame: 8 weeks
description: A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
measure: Proportion of Subjects With Near Control Treatment Response
time frame: 8 weeks
description: A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
arm group label: Overminus Treatment
arm group type: Experimental
description: 2.50D overminus spectacles
arm group label: Non-overminus Treatment
arm group type: Active Comparator
description: spectacles without overminus or no spectacles
intervention type: Device
intervention name: Overminus treatment
description: 2.50D overminus spectacles
arm group label: Overminus Treatment
other name: Overminus spectacles
other name: Overminus glasses
other name: Overminus therapy
intervention type: Device
intervention name: Non-overminus treatment
description: spectacles without overminus or no spectacles
arm group label: Non-overminus Treatment
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: No
last name: Jonathan M Holmes, MD
role: Study Chair
affiliation: Mayo Clinic
last name: Angela M Chen, OD, MS
role: Study Chair
affiliation: Marshall B. Ketchum University
facility: 
facility: 
country: United States
url: http://pedig.jaeb.org
description: PEDIG Public Website
citation: Pediatric Eye Disease Investigator Group; Chen AM, Holmes JM, Chandler DL, Patel RA, Gray ME, Erzurum SA, Wallace DK, Kraker RT, Jensen AA. A Randomized Trial Evaluating Short-term Effectiveness of Overminus Lenses in Children 3 to 6 Years of Age with Intermittent Exotropia. Ophthalmology. 2016 Oct;123(10):2127-36. doi: 10.1016/j.ophtha.2016.06.042. Epub 2016 Aug 6.
PMID: 27506485
responsible party type: Sponsor
mesh term: Exotropia
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.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size; only 8-weeks of follow up; high test-retest variability of control; some regression to the mean may be present; do not know if treatment effect would persist after overminus lenses are replaced with usual spectacle correction.
point of contact: 