Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS07 - Bilateral Refractive Amblyopia Treatment Study: Response to Treatment of Previously Untreated Presumed Bilateral Refractive Amblyopia
Status: Closed
Start Date: 08/02/2004
End Date: 10/10/2006
Clinical Trial ID: NCT00305955
Public Dataset:  Download


Bilateral Refractive Amblyopia Treatment Study: Response to Treatment of Previously Untreated Presumed Bilateral Refractive Amblyopia

Protocol

Objectives:
  • To determine the amount of visual acuity improvement with treatment of presumed bilateral refractive amblyopia.
  • To determine the time course of visual acuity improvement with treatment.

Summary of Results:
113 children (mean age = 5.1 years) with previously untreated bilateral refractive amblyopia were enrolled at 27 community- and university-based sites and were provided optimal spectacle correction. Mean binocular visual acuity improved from 0.50 logMAR (20/63) at baseline to 0.11 logMAR (20/25) at one year (mean improvement 3.9 lines, 95% confidence interval [CI] = 3.5 to 4.2). Mean improvement at one year for the 84 children with baseline binocular acuity of 20/40 to 20/80 was 3.4 lines (95% CI = 3.2 to 3.7) and for the 16 children with baseline binocular acuity of 20/100 to 20/320 was 6.3 lines (95% CI = 5.1 to 7.5). The cumulative probability of binocular acuity of 20/25 or better was 21% at 5 weeks, 46% at 13 weeks, 59% at 26 weeks, and 74% at 52 weeks.

Treatment of bilateral refractive amblyopia with spectacle correction improves binocular visual acuity in children age 3 to <10 years old, with most improving to 20/25 or better within one year.

Published:
  1. Pediatric Eye Disease Investigator Group. Treatment of bilateral refractive amblyopia in children three to less than 10 years of age. Am J Ophthalmol 2007;144:487-96.

 



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