Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS02A - A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
Status: Closed
Start Date: 05/08/2001
End Date: 08/01/2003
Clinical Trial ID: NCT00094744
Public Dataset:  Download


A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia

Protocol

Objectives:
To compare 6 hours versus full-time daily patching as treatments for severe 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, 175 children less than 7 years of age with amblyopia in the range of 20/100 to 20/400 were assigned to prescription of either 6 hours or full-time daily patching combined with at least one hour per day of near visual activities while patching. The four-month outcome visit was completed by 157 (90%) of the 175 patients.

Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the amblyopic eye acuity from baseline to four months averaged 4.8 lines in the six-hour group and 4.7 lines in the full-time group (P=0.45). The mean difference between groups in logMAR acuity adjusted for baseline acuity = -0.03, 95% confidence interval, -0.11 to 0.05.

Conclusion:
For severe amblyopia, prescribing six hours of daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by prescribing full-time 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 severe amblyopia in children. Ophthalmology 2003;110:2075-87.

 



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