<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/NCT03825107</url>
  </required_header>
  <id_info>
    <org_study_id>Dichoptic Video for Amblyopia</org_study_id>
    <nct_id>NCT03825107</nct_id>
  </id_info>
  <brief_title>Dichoptic Video Treatment for Amblyopia</brief_title>
  <official_title>Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Retina Foundation of the Southwest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Retina Foundation of the Southwest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To determine whether watching contrast-rebalanced dichoptic videos is effective in&#xD;
           improving visual acuity and reducing interocular suppression in amblyopic children&#xD;
&#xD;
        2. To compare the amount of visual acuity improvement achieved with the videos to tha&#xD;
           amount achieved with patching (standard treatment for amblyopia)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been&#xD;
      shown to be an effective treatment for amblyopia. However, the games can be challenging for&#xD;
      some of the youngest children and boring for some of the older children with amblyopia. To&#xD;
      provide additional treatment options using the same contrast-rebalancing approach, we have&#xD;
      processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic&#xD;
      eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch&#xD;
      dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care&#xD;
      amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the&#xD;
      patching group will cross over to the videos and return for a secondary outcome visit at 4&#xD;
      weeks. Families will have the option to continue with the vdeos for up to 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 6, 2021</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>
    <intervention_model_description>Parallel for primary outcome; crossover for longterm effectiveness</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual acuity of the amblyopic eye</measure>
    <time_frame>Baseline vs 2 weeks</time_frame>
    <description>HOTV (preferred) or picture chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in visual acuity of the amblyopic eye</measure>
    <time_frame>Baseline vs 4 weeks, 6 weeks, and 8 weeks</time_frame>
    <description>HOTV (preferred) or picture charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stereoacuity</measure>
    <time_frame>Baseline vs 2, 4, 6, 8 weeks</time_frame>
    <description>Randot Preschool Stereoacuity test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Contrast Balance Index</measure>
    <time_frame>Baseline vs 2, 4, 6, 8 weeks</time_frame>
    <description>Dichoptic Letter chart</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Patching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 hours per day 7 days per week patching of the fellow eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dichoptic Videos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>watching 6 dichoptic videos during each 2 week period</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patching</intervention_name>
    <description>covering the fellow eye with an eyepatch to force use of the amblyopic eye</description>
    <arm_group_label>Patching</arm_group_label>
    <other_name>occlusion therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dichoptic videos</intervention_name>
    <description>watching contrast-rebalanced dichoptic videos to allow the two eyes to work together</description>
    <arm_group_label>Dichoptic Videos</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 to 7 years old&#xD;
&#xD;
          -  Amblyopic eye visual acuity 20/32-20/125&#xD;
&#xD;
          -  Fellow eye visual acuity 20/16-25&#xD;
&#xD;
          -  Interocular visual acuity difference of at least 2 lines&#xD;
&#xD;
          -  Anisometropia or corrected strabsimus (&lt;5pd)&#xD;
&#xD;
          -  in glasses at least 8 weeks or no change in visual acuity over two visits&#xD;
&#xD;
          -  no prior binocular treatment&#xD;
&#xD;
          -  must be able to see full video screen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prematurity of 8 weeks or more&#xD;
&#xD;
          -  coexisting ocular or systemic disease&#xD;
&#xD;
          -  developmental delay&#xD;
&#xD;
          -  poor ocular alignment (&gt;=5 pd)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eileen E Birch, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Retina Foundation of the Southwest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eileen E Birch</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Retina Foundation of the Southwest</investigator_affiliation>
    <investigator_full_name>Eileen Birch</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03825107/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03825107/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03825107
org study id: Dichoptic Video for Amblyopia
nct id: NCT03825107
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. To determine whether watching contrast-rebalanced dichoptic videos is effective in
           improving visual acuity and reducing interocular suppression in amblyopic children

        2. To compare the amount of visual acuity improvement achieved with the videos to tha
           amount achieved with patching (standard treatment for amblyopia)
Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been
      shown to be an effective treatment for amblyopia. However, the games can be challenging for
      some of the youngest children and boring for some of the older children with amblyopia. To
      provide additional treatment options using the same contrast-rebalancing approach, we have
      processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic
      eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch
      dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care
      amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the
      patching group will cross over to the videos and return for a secondary outcome visit at 4
      weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel for primary outcome; crossover for longterm effectiveness
primary purpose: Treatment
masking: None (Open Label)
measure: Change in visual acuity of the amblyopic eye
time frame: Baseline vs 2 weeks
description: HOTV (preferred) or picture chart
measure: Change in visual acuity of the amblyopic eye
time frame: Baseline vs 4 weeks, 6 weeks, and 8 weeks
description: HOTV (preferred) or picture charts
measure: Change in Stereoacuity
time frame: Baseline vs 2, 4, 6, 8 weeks
description: Randot Preschool Stereoacuity test
measure: Change in Contrast Balance Index
time frame: Baseline vs 2, 4, 6, 8 weeks
description: Dichoptic Letter chart
arm group label: Patching
arm group type: Active Comparator
description: 2 hours per day 7 days per week patching of the fellow eye
arm group label: Dichoptic Videos
arm group type: Experimental
description: watching 6 dichoptic videos during each 2 week period
intervention type: Other
intervention name: patching
description: covering the fellow eye with an eyepatch to force use of the amblyopic eye
arm group label: Patching
other name: occlusion therapy
intervention type: Other
intervention name: Dichoptic videos
description: watching contrast-rebalanced dichoptic videos to allow the two eyes to work together
arm group label: Dichoptic Videos
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
last name: Eileen E Birch, PhD
role: Principal Investigator
affiliation: Retina Foundation of the Southwest
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Retina Foundation of the Southwest
investigator full name: Eileen Birch
investigator title: Senior Research Scientist
mesh term: Amblyopia
sharing ipd: No
provided document: 
provided document: 