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 ]

Monocular distance visual acuity in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children <7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes


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