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Randomized Controlled Trial
. 2008 Dec;126(12):1634-42.
doi: 10.1001/archophthalmol.2008.107.

Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial

Mitchell M Scheiman  1 , Richard W Hertle, Raymond T Kraker, Roy W Beck, Eileen E Birch, Joost Felius, Jonathan M Holmes, James Kundart, David G Morrison, Michael X Repka, Susanna M Tamkins; Pediatric Eye Disease Investigator Group
Collaborators, Affiliations
Randomized Controlled Trial

Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial

Mitchell M Scheiman et al. Arch Ophthalmol. 2008 Dec.

Abstract

Objective: To compare patching with atropine eyedrops in the treatment of moderate amblyopia (visual acuity, 20/40-20/100) in children aged 7 to 12 years.

Methods: In a randomized, multicenter clinical trial, 193 children with amblyopia were assigned to receive weekend atropine or patching of the sound eye 2 hours per day. Main Outcome Measure Masked assessment of visual acuity in the amblyopic eye using the electronic Early Treatment Diabetic Retinopathy Study testing protocol at 17 weeks.

Results: At 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group. The mean difference between groups (patching - atropine) adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority, -0.7, 3.1 letters). This difference met the prespecified definition for equivalence (confidence interval <5 letters). Visual acuity in the amblyopic eye was 20/25 or better in 15 participants in the atropine group (17%) and 20 in the patching group (24%; difference, 7%; 95% confidence interval, -3% to 17%).

Conclusions: Treatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia. About 1 in 5 achieved visual acuity of 20/25 or better in the amblyopic eye.

Clinical relevance: Atropine and patching achieve similar results among older children with unilateral amblyopia.

Trial registration: (clinicaltrials.gov) Identifier: NCT00315328.

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Figures

Figure 1
Figure 1
Flow chart showing study completion in each treatment group.
Figure 2
Figure 2
Cumulative distribution of amblyopic eye visual acuity scores at 17-week outcome exam according to treatment group.
See this image and copyright information in PMC

References

    1. Pediatric Eye Disease Investigator Group Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005;123:437–47. - PubMed
    1. Beck RW, Moke PS, Turpin AH, et al. A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol. Am J Ophthalmol. 2003;135:194–205. - PubMed
    1. Moke PS, Turpin AH, Beck RW, et al. Computerized method of visual acuity testing: adaptation of the amblyopia treatment study visual acuity testing protocol. Am J Ophthalmol. 2001;132:903–9. - PubMed
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    1. Pediatric Eye Disease Investigator Group A randomized trial of atropine regimens for treatment of moderate amblyopia in children. Ophthalmology. 2004;111:2076–85. - PubMed

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