Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Patching; Near activities; Active vision therapy; Control vision therapy
Intervention description: 2 hours daily patching; 30 minutes daily near activities at home; 30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session; 30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 7 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Amblyopia; Vision Therapy; Patching

Summary:

      This study is comparing the effectiveness of patching combined with active vision therapy
      plus near activities versus patching combined with control vision therapy plus near
      activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds.

      The primary outcome measure is the proportion of patients with visual acuity of 20/25 or
      better in the amblyopic eye at the 17-week masked exam. These patients will be considered
      treatment responders. The primary analysis will consist of a comparison between the 2
      treatment groups of the proportion of treatment responders with adjustment for baseline
      visual acuity.

      Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual
      acuity at the 17-week masked exam, and rate of improvement of visual acuity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 7 to <13 years

          -  Amblyopia associated with anisometropia, strabismus (comitant or incomitant), or both
             at the time of the eligibility examination

          -  Visual acuity in the amblyopic eye between 49 and 71 letters inclusive (20/40 to
             20/100 inclusive) on the eETDRS

          -  Visual acuity in the sound eye of 79 or more letters on the eETDRS (20/25 or better)

          -  Inter-eye acuity difference of 15 or more letters (3 or more logMAR lines)

          -  At least 800 seconds of arc on the Randot Preschool Stereoacuity Test

          -  Previous or current amblyopia treatment with spectacles or contact lenses, patching or
             atropine is permitted.

          -  No myopia more than -6.00 D spherical equivalent in the amblyopic eye

          -  Single vision spectacles, if needed, worn for at least 16 weeks or until visual acuity
             documented to be stable

          -  The child has access to a computer on a daily basis (to use the home vision therapy
             software)

        Exclusion Criteria:

          -  Previous vision therapy or orthoptics

          -  Known skin reactions to patch or bandage adhesives

          -  Prior intraocular or refractive surgery

          -  Bifocals

          -  Constant strabismus at near at the eligibility examination

          -  A family member is (or has been) enrolled in this study