<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/NCT03288948</url>
  </required_header>
  <id_info>
    <org_study_id>062010-105</org_study_id>
    <nct_id>NCT03288948</nct_id>
  </id_info>
  <brief_title>Binocular Amblyopia Treatment</brief_title>
  <official_title>Binocular Amblyopia Treatment</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>
      To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more&#xD;
      complete and stable recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same&#xD;
      10% per day contrast-increment that was designed for short-term intervention studies lasting&#xD;
      1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no&#xD;
      contrast-rebalancing).This study will investigate two alternative protocols designed to&#xD;
      extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual&#xD;
      acuity. The new protocols will be compared with the original 10% contrast-increment game&#xD;
      protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more&#xD;
      effective than the current 10% increment.&#xD;
&#xD;
      Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual&#xD;
      acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who&#xD;
      attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit&#xD;
      for the next 4 weeks. Children with residual amblyopia (BCVA &gt;0.4 logMAR) at the 8-week visit&#xD;
      will be provided with dichoptic movies for additional amblyopia treatment for another 4&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual acuity of the amblyopic eye</measure>
    <time_frame>baseline vs 8 weeks</time_frame>
    <description>ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in visual acuity of the amblyopic eye</measure>
    <time_frame>baseline vs 2, 4, 6, and 12 weeks</time_frame>
    <description>ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stereoacuity</measure>
    <time_frame>baseline vs 2, 4, 6, 8, 12 weeks</time_frame>
    <description>Randot Preschool Stereoacuity Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in suppression</measure>
    <time_frame>baseline vs 2, 4, 6, 8, 12 weeks</time_frame>
    <description>Dichoptic Letter Chart</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in accommodation</measure>
    <time_frame>baseline vs 8 week</time_frame>
    <description>Accuracy of accommodation to a near target (Grand Seiko)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in motion perception</measure>
    <time_frame>baseline vs 8 weeks</time_frame>
    <description>Motion-defined form</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in fixation stability</measure>
    <time_frame>baseline vs 8 weeks</time_frame>
    <description>Bivariate contour ellipse area</description>
  </other_outcome>
  <other_outcome>
    <measure>Reading speed</measure>
    <time_frame>baseline vs 4 and 8 weeks</time_frame>
    <description>Reading speed in wpm</description>
  </other_outcome>
  <other_outcome>
    <measure>Fine motor skills</measure>
    <time_frame>baseline vs 4 and 8 weeks</time_frame>
    <description>M-ABC</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-perception</measure>
    <time_frame>baseline vs 8 weeks</time_frame>
    <description>self-perception questionnaire</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Amblyopia</condition>
  <arm_group>
    <arm_group_label>Standard Contrast Increment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Reduced Contrast Increment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Contrast Increment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Binocular games for treatment of amblyopia</intervention_name>
    <description>playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye</description>
    <arm_group_label>No Contrast Increment</arm_group_label>
    <arm_group_label>Reduced Contrast Increment</arm_group_label>
    <arm_group_label>Standard Contrast Increment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 4-10 y&#xD;
&#xD;
          -  male and female&#xD;
&#xD;
          -  strabismic, anisometropic, or combined mechanism amblyopia&#xD;
&#xD;
          -  amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR&#xD;
&#xD;
          -  fellow eye best-corrected visual acuity ≤0.1 logMAR&#xD;
&#xD;
          -  interocular visual acuity difference ≥0.3 logMAR&#xD;
&#xD;
          -  wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2&#xD;
             visits&#xD;
&#xD;
               -  4 weeks apart.&#xD;
&#xD;
          -  child's ophthalmologist and family must be willing to forgo patching treatment during&#xD;
             the 12-week study period&#xD;
&#xD;
          -  parent's informed consent&#xD;
&#xD;
          -  child must demonstrate understanding and ability to play binocular games&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prematurity ≥8 weeks&#xD;
&#xD;
          -  coexisting ocular or systemic disease&#xD;
&#xD;
          -  developmental delay&#xD;
&#xD;
          -  strabismus &gt;5pd&#xD;
&#xD;
          -  any binocular amblyopia treatment in the past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Reed Jost, MS</last_name>
    <phone>2143633911</phone>
    <phone_ext>113</phone_ext>
    <email>reedjost@retinafoundation.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Krista Kelly, PhD</last_name>
    <phone>2143633911</phone>
    <phone_ext>113</phone_ext>
    <email>kkelly@rfsw.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Retina Foundation of the Southwest</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pediatric Laboratory</last_name>
      <phone>214-363-3911</phone>
      <phone_ext>113</phone_ext>
    </contact>
    <investigator>
      <last_name>Eileen E Birch, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</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>
    <ipd_description>we will only share aggregated data</ipd_description>
  </patient_data>
  <!-- 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/NCT03288948
org study id: 062010-105
nct id: NCT03288948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more
      complete and stable recovery.
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same
      10% per day contrast-increment that was designed for short-term intervention studies lasting
      1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no
      contrast-rebalancing).This study will investigate two alternative protocols designed to
      extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual
      acuity. The new protocols will be compared with the original 10% contrast-increment game
      protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more
      effective than the current 10% increment.

      Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual
      acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who
      attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit
      for the next 4 weeks. Children with residual amblyopia (BCVA >0.4 logMAR) at the 8-week visit
      will be provided with dichoptic movies for additional amblyopia treatment for another 4
      weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in visual acuity of the amblyopic eye
time frame: baseline vs 8 weeks
description: ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
measure: Change in visual acuity of the amblyopic eye
time frame: baseline vs 2, 4, 6, and 12 weeks
description: ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
measure: Change in stereoacuity
time frame: baseline vs 2, 4, 6, 8, 12 weeks
description: Randot Preschool Stereoacuity Test
measure: Change in suppression
time frame: baseline vs 2, 4, 6, 8, 12 weeks
description: Dichoptic Letter Chart
measure: Change in accommodation
time frame: baseline vs 8 week
description: Accuracy of accommodation to a near target (Grand Seiko)
measure: Change in motion perception
time frame: baseline vs 8 weeks
description: Motion-defined form
measure: Change in fixation stability
time frame: baseline vs 8 weeks
description: Bivariate contour ellipse area
measure: Reading speed
time frame: baseline vs 4 and 8 weeks
description: Reading speed in wpm
measure: Fine motor skills
time frame: baseline vs 4 and 8 weeks
description: M-ABC
measure: Self-perception
time frame: baseline vs 8 weeks
description: self-perception questionnaire
arm group label: Standard Contrast Increment
arm group type: Active Comparator
arm group label: Reduced Contrast Increment
arm group type: Experimental
arm group label: No Contrast Increment
arm group type: Experimental
intervention type: Other
intervention name: Binocular games for treatment of amblyopia
description: playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye
arm group label: No Contrast Increment
arm group label: Reduced Contrast Increment
arm group label: Standard Contrast Increment
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
last name: Reed Jost, MS
phone: 2143633911
phone ext: 113
email: reedjost@retinafoundation.org
last name: Krista Kelly, PhD
phone: 2143633911
phone ext: 113
email: kkelly@rfsw.org
facility: 
status: Recruiting
contact: 
investigator: 
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
ipd description: we will only share aggregated data