Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Eye Patch; Eye Patch
Intervention description: 42 hours patching per week (averaging 6 hours patching daily); 2 hours patching daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 3 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Amblyopia; patching; occlusion

Summary:

      This study is designed to evaluate the effectiveness of increasing prescribed patching
      treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment
      and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to
      20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching
      until no improvement, followed by randomization of eligible patients to patching 2 hours
      daily versus an average of 6 hours daily (42 hours per week). The primary objective is to
      determine if increasing patching dosage will improve visual acuity in patients with amblyopia
      still present after visual acuity has stabilized with initial treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Major Eligibility Criteria for Run-in Phase

          -  Age 3 to < 8 years

          -  Amblyopia associated with strabismus, anisometropia, or both

          -  Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive

          -  Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3
             logMAR lines

          -  Amblyopia treatment within the past 6 months subject to the following stipulations:

               -  No more than 6 weeks of any amblyopia treatment other than spectacles (except for
                  patients being treated with 2 hours of patching per day who are entering the
                  study on treatment)

               -  No simultaneous treatment with patching and atropine

               -  No use of atropine in combination with the sound eye spectacle lens reduced by
                  more than 1.50 D

               -  Maximum level of treatment within the past 6 months:

                    -  Patching: up to 2 hours daily

                    -  Atropine: up to once daily

          -  Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is
             20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100
             or worse, then spectacles and patching can be initiated simultaneously.

        Eligibility Criteria for Randomization:

          -  Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines,
             or amblyopic eye acuity of 20/32 with 3 lines of IOD.

          -  Reasonable compliance with prescribed treatment, defined as wearing the patch at least
             10 hours per week.

        Exclusion Criteria:

          -  Currently using vision therapy or orthoptics

          -  Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient
             if the above visual acuity criteria are met)

          -  Prior intraocular or refractive surgery

          -  Known skin reaction to patch or bandage adhesives