Clinical Trial: Binocular Dig Rush Game Treatment for Amblyopia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Binocular Dig Rush Game Treatment for Amblyopia

Brief Summary: The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Detailed Summary:
Sponsor: Jaeb Center for Health Research

Current Primary Outcome: Mean change in amblyopic-eye VA [ Time Frame: 4 weeks ]

For both age cohorts, the primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • VA Improvement at 4 Weeks Defined as a Binary Outcome [ Time Frame: At 4 weeks ]
    A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.
  • VA Improvement at 8 Weeks Defined as a Binary Outcome [ Time Frame: At 8 weeks ]
    A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.
  • Stereoacuity [ Time Frame: 4 weeks ]
    Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity will be tabulated at baseline and 4 weeks according to treatment group.
  • Stereoacuity [ Time Frame: 8 weeks ]
    Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity will be tabulated at 8 weeks according to treatment group.
  • Treatment Compliance with Binocular Therapy [ Time Frame: At 4 weeks ]
    Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment. The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.
  • Treatment Compliance with Binocular Therapy at 8 weeks [ Time Frame: At 8 weeks ]
    Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment. The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.
  • Fellow-eye Contrast with Binocular Therapy [ Time Frame: 4 weeks ]
    Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.
  • Fellow-eye Contrast with Binocular Therapy at 8 Weeks [ Time Frame: 8 weeks ]
    Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment.
  • VA in Fellow Eye [ Time Frame: 4 weeks ]
    The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
  • VA in Fellow Eye at 8 Weeks [ Time Frame: 8 weeks ]
    The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
  • Ocular Alignment [ Time Frame: 4 weeks ]
    The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.
  • Ocular Alignment at 8 Weeks [ Time Frame: 8 weeks ]
    The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.
  • Diplopia [ Time Frame: 4 weeks ]
    The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. Data will also be tabulated based on the maximum frequency of diplopia reported by treatment group.
  • Diplopia at 8 Weeks [ Time Frame: 8 weeks ]

    Original Secondary Outcome: Same as current

    Information By: Jaeb Center for Health Research

    Dates:
    Date Received: November 16, 2016
    Date Started: March 2, 2017
    Date Completion: April 2019
    Last Updated: April 7, 2017
    Last Verified: April 2017