Clinical Trial: Study of Binocular Computer Activities for Treatment of Amblyopia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study of Binocular Computer Activities for Treatment of Amblyopia
Brief Summary: The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play 7 days per week with 2 hours/day patching 7 days per week in children 5 to <17
Detailed Summary: The purpose of the study is to 1) compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week, in children 5 to <13 years of age (younger cohort), as a non-inferiority study; and 2) to compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week, in children 13 to <17 years of age (older cohort), as a superiority study.
Sponsor: Jaeb Center for Health Research
Current Primary Outcome: Distance Visual Acuity [ Time Frame: 16 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Stereoacuity [ Time Frame: 16 weeks ]Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests
- Ocular Alignment [ Time Frame: 16 weeks ]Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter)
- Diplopia Questionnaire [ Time Frame: 16 weeks ]The child and parent(s) will be specifically questioned regarding the presence and frequency of any diplopia since the last study visit using a standardized diplopia assessment
Original Secondary Outcome: Same as current
Information By: Jaeb Center for Health Research
Dates:
Date Received: July 23, 2014
Date Started: September 11, 2014
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017