Clinical Trials
February 2005

Two-Year Follow-up of a 6-Month Randomized Trial of Atropine vs Patching for Treatment of Moderate Amblyopia in Children

The Pediatric Eye Disease Investigator Group*
Author Affiliations

W. BECKROYMD, PhD*The writing committee served as author for the Pediatric Eye Disease Investigator Group (PEDIG). A complete list of writing committee members is as follows: lead authors: Michael X. Repka, MD; David K. Wallace, MD; Roy W. Beck, MD, PhD; Raymond T. Kraker, MSPH. Additional writing committee members (alphabetical): Eileen E. Birch, PhD; Susan A. Cotter, OD; Sean Donahue, MD; Donald F. Everett, MA; Richard W. Hertle, MD; Jonathan M. Holmes, BM, BCh; Graham E. Quinn, MD, MSCE; Mitchell M. Scheiman, OD; David R. Weakley, MD.


Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005

Arch Ophthalmol. 2005;123(2):149-157. doi:10.1001/archopht.123.2.149

Objective  To compare patching and atropine sulfate as treatments for moderate amblyopia in children 18 months after completion of a 6-month randomized trial.

Methods  In a randomized, multicenter (47 sites) clinical trial, 419 children younger than 7 years with amblyopia (20/40 to 20/100 in the affected eye) were assigned to receive either patching or atropine eye drops for 6 months. Between 6 months and 2 years, treatment was at the discretion of the investigator.

Main Outcome Measure  Visual acuity in the amblyopic eye and sound eye after 2 years.

Results  At 2 years, visual acuity in the amblyopic eye improved from baseline a mean of 3.7 lines in the patching group and 3.6 lines in the atropine group. The difference in visual acuity between treatment groups was small: 0.01 logMAR (95% confidence interval, −0.02 to 0.04). In both treatment groups, the mean amblyopic eye acuity was approximately 20/32, 1.8 lines worse than the mean sound eye acuity, which was approximately 20/20.

Conclusions  Atropine or patching for 6 months followed by best clinical care until 2 years produced similar improvement of moderate amblyopia in children between 3 and 7 years of age at enrollment. However, on average the amblyopic eye acuity was still approximately 2 lines worse than the sound eye.