Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS04 - A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia
Status: Closed
Start Date: 06/03/2002
End Date: 12/31/2003
Clinical Trial ID: NCT00094614
Public Dataset:  


A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia

Protocol

Objective:
To compare daily atropine to weekend atropine as prescribed treatments for moderate amblyopia in children younger than 7 years.

Design:
Prospective, randomized multicenter clinical trial (30 sites).

Participants:
One hundred sixty-eight children younger than 7 years with amblyopia in the range of 20/40 to 20/80 associated with strabismus, anisometropia, or both.

Intervention:
Randomization either to daily atropine or to weekend atropine for 4 months. Partial responders were continued on the randomized treatment until no further improvement was noted.
Main outcome measure: Visual acuity in the amblyopic eye after 4 months.

Results:
The improvement in visual acuity of the amblyopic eye from baseline to 4 months averaged 2.3 lines in each group. The visual acuity of the amblyopic eye at study completion was either (1) at least 20/25 or (2) better than or equal to the sound eye in 39 children (47%) in the daily group and 45 children (53%) in the weekend group. The visual acuity of the sound eye at the end of follow-up was reduced by 2 lines in one patient in each group. Stereoacuity outcomes were similar in the two groups.

Conclusions:
Weekend atropine provides an improvement in visual acuity that is of similar magnitude to the improvement provided by daily atropine in treating moderate amblyopia in children aged 3 to 7 years.

 

Published:

  1. Pediatric Eye Disease Investigator Group. A randomized trial of atropine regimens for treatment of moderate amblyopia in children. Ophthalmology 2004;111:2076-85.
  2. Christoff A, Repka MX, Kaminski BM, Holmes JM, on behalf of the Pediatric Eye Disease Investigator Group. Distance versus near visual acuity in amblyopia. J AAPOS 2011;15(4):342-4.

 



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