Combined Patching-Atropine for Residual Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Patching; Atropine; Patching; Atropine
Intervention description: 42 hours per week of patching; daily atropine (1%); two hours of daily patching for 4 weeks, then no treatment; once weekly atropine for 4 weeks, then no treatment
Intervention MeSH terms: Atropine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: No
Keywords: Amblyopia; Atropine; Patching

Summary:

      This study is designed to evaluate the effectiveness of treatment of residual amblyopia in
      children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The
      study is a randomized clinical trial comparing intensive treatment (42 hours per week of
      patching plus daily atropine) with a control group that will have rapid weaning of existing
      treatment followed by spectacle correction only (if needed). The primary objective is to
      determine if this intensive treatment will improve visual acuity in patients with residual
      amblyopia.

      The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

      The primary analytic approach for the amblyopic eye acuity will be a treatment group
      comparison of the proportion of patients with at least two lines of visual acuity
      improvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 to < 10 years

          -  Amblyopia associated with strabismus, anisometropia, or both

          -  Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive

          -  Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2
             logMAR lines

          -  Current/previous treatment with patching and/or atropine subject to the following
             stipulations:

               -  No simultaneous treatment with patching and atropine in the past 6 months

               -  No prior use of atropine in combination with the sound eye spectacle lens reduced
                  by more than 1.50 D

               -  Maximum level of any previous treatment:

                    -  Patching: up to 42 hours per week (averaging 6 hours daily)

                    -  Atropine: up to once daily

               -  Current treatment with 42 hours per week patching or daily atropine

          -  No improvement in best-corrected amblyopic eye visual acuity between two consecutive
             visits at least 6 weeks apart using the same testing method and optimal spectacle
             correction (if needed), with no improvement defined as follows:

               -  No lines of improvement

               -  For patients tested using E-ETDRS, letter score that is no more than 4 letters
                  improved

          -  Wearing spectacles with optimal correction (if applicable)

          -  Investigator ready to wean or stop treatment

        Exclusion Criteria:

          -  Current vision therapy or orthoptics

          -  Ocular cause for reduced visual acuity

          -  Prior intraocular or refractive surgery

          -  Strabismus surgery planned within 10 weeks

          -  Known allergy to atropine or other cycloplegic drugs

          -  Known skin reactions to patch or bandage adhesives

          -  Down Syndrome present