Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS08 - A Randomized Trial Comparing Atropine to Atropine plus a Plano Lens for the Sound Eye as Prescribed Treatments for Amblyopia in Children 3 to < 7 Years Old
Status: Closed
Start Date: 02/01/2005
End Date: 01/29/2008
Clinical Trial ID: NCT00315302
Public Dataset:  Download


A Randomized Trial Comparing Atropine to Atropine plus a Plano Lens for the Sound Eye as Prescribed Treatments for Amblyopia in Children 3 to < 7 Years Old

Protocol

Objectives:

  • To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to <7 years old.
  • To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Methods:
In a multicenter clinical trial, 180 children with moderate amblyopia (visual acuities of 20/40-20/100) were randomized to weekend atropine use augmented by a plano lens or weekend atropine use alone.

Main Outcome Measure:
Masked assessment of amblyopic eye visual acuity using the Amblyopia Treatment Study HOTV testing protocol at 18 weeks.

Results:
At 18 weeks, amblyopic eye improvement averaged 2.8 lines in the group that received atropine plus a plano lens and 2.4 lines in the group that received atropine alone (mean difference between groups adjusted for baseline acuity, 0.3 line; 95% confidence interval, −0.2 to 0.8 line). Amblyopic eye visual acuity was 20/25 or better in 24 patients (29%) in the group that received atropine only and 35 patients (40%) in the group that received atropine plus a plano lens (P=.03). More patients in the group that received atropine plus a plano lens had reduced sound eye visual acuity at 18 weeks; however, there were no cases of persistent reverse amblyopia.

Conclusions:
As an initial treatment for moderate amblyopia, the augmentation of weekend atropine use with a plano lens does not substantially improve amblyopic eye visual acuity when compared with weekend atropine use alone.

Published:
  1. Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmology 2009;127:22-30.
  2. Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS 2009;13:258-63.

 



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