Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS02B - A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia
Status: Closed
Start Date: 05/07/2001
End Date: 09/01/2002
Clinical Trial ID: NCT00094679
Public Dataset:  Download


A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia

Protocol

Objective:
To compare 2 hours versus 6 hours of daily patching as treatments for moderate amblyopia in children less than 7 years of age over a 4-month follow-up period.

Summary of Results:
In a randomized multi-center clinical trial, 189 children less than 7 years of age with amblyopia in the range of 20/40 to 20/80 were assigned to prescriptionof either 2 hours or 6 hours of daily patching combined with at least one hour per day of near visual activities while patching. The four-month outcome visit was completed by 181 (96%) of the 189 patients.

Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the amblyopic eye acuity from baseline to 4 months averaged 2.40 lines in each group (P=0.98). The mean difference in logMAR acuity between groups = 0.001, 95% confidence interval, -0.040 to 0.042.

Conclusion:
For moderate amblyopia, prescribing two hours of daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by prescribing six hours of daily patching in children 3 to less than 7 years of age.

Published:
  1. Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003;121:603-11.

 



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