Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Bangerter filters; Patching; Near activities
Intervention description: Bangerter filter worn on sound eye spectacle lens full time; 2 hours daily patching of the sound eye; one hour near visual activities
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: No
Keywords: Amblyopia; Patching; Bangerter filters

Summary:

      This study is a randomized clinical trial designed to evaluate the non-inferiority of
      Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate
      amblyopia (20/40 to 20/80) in children ages 3 to < 10 years.

      Secondary objectives of this study are (1) to determine the time course of visual improvement
      with Bangerter filter treatment, (2) to compare patient quality of life, measured by a
      modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter
      filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the
      amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in
      fixation to the amblyopic eye is predictive of improvement in visual acuity.

      The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound
      eyes.

      The primary analytic approach for the amblyopic eye acuity will involve construction of a
      one-sided 95% confidence interval to assess non-inferiority based on a treatment group
      comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an
      analysis of covariance (ANCOVA) model.

      Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as
      mean change (logMAR lines) from baseline and as the distribution of the number of lines of
      change from baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 to < 10 years

          -  Amblyopia associated with strabismus, anisometropia, or both

          -  No ocular cause apparent for reduced visual acuity

          -  Visual acuity 20/40 to 20/80 (71 to 54 letters inclusive) in amblyopic eye

          -  Visual acuity 20/40 or better (>= 69 letters) in sound eye

          -  Interocular difference >= 3 logMAR lines (>= 15 letters)

          -  No amblyopia treatment other than spectacles in last 6 months

             *Any treatment more than 6 months prior to enrollment is acceptable

          -  Currently wearing spectacles

          -  Appropriate spectacles have been worn for 16 weeks prior to enrollment or visual
             acuity documented to be stable

          -  No myopia > -6.00 D spherical equivalent in either eye

          -  Cycloplegic refraction within 6 months prior to enrollment

          -  Ocular examination within 6 months prior to enrollment

        Exclusion Criteria:

          -  Current vision therapy or orthoptics

          -  Ocular cause for reduced visual acuity

          -  Prior intraocular or refractive surgery

          -  Known skin reactions to patch or bandage adhesives