Protocol: ATS10 - A Randomized Trial of Full-time Bangerter Filters versus Part-time Daily Patching for the Treatment of Moderate Amblyopia in Children
Status: Closed
Start Date: 11/09/2007
End Date: 07/31/2008
Clinical Trial ID: NCT00525174
Public Dataset:  Download


A Randomized Trial of Full-time Bangerter Filters versus Part-time Daily Patching for the Treatment of Moderate Amblyopia in Children
Protocol

Objectives:

  • Primary:
    • To evaluate the non-inferiority of Bangerter filters to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 – 20/80) in children ages 3 to <10 years.
  • Secondary:
    • To determine the time course of visual improvement with Bangerter filter treatment.
    • To compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters.
    • To determine whether the degree of blurring of sound eye visual acuity relative to the amblyopic eye visual acuity predicts improvement in acuity.
    • To determine whether fixation preference is predictive of improvement in visual acuity.

Publications:

  1. Pediatric Eye Disease Investigator Group. A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children. Ophthalmology 2010;117(5):998-1004.
  2. Rutstein RP, Foster NC, Cotter SA, et al. for the Pediatric Eye Disease Investigator Group. Visual acuity through Bangerter filters in nonamblyopic eyes. J AAPOS 2011;15(2):131-4.

 



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