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Randomized Controlled Trial
. 2009 Jan;127(1):22-30.
doi: 10.1001/archophthalmol.2008.520.

Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial

Pediatric Eye Disease Investigator Group
Collaborators
Randomized Controlled Trial

Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial

Pediatric Eye Disease Investigator Group. Arch Ophthalmol. 2009 Jan.

Abstract

Objective: To compare weekend atropine sulfate use augmented by a plano lens for the sound eye with weekend atropine use alone for moderate amblyopia in children aged 3 years to younger than 7 years.

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. Application to Clinical Practice Treatment of children with unilateral amblyopia. Trial Registration clinicaltrials.org Identifier: NCT00315302.

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Figures

Figure 1
Figure 1. Visit Completion
Flow chart showing study completion in each treatment group.
Figure 2
Figure 2. Rate of Improvement in Amblyopic Eye Visual Acuity
Amblyopic eye visual acuity in each group at baseline, 5 weeks, 10 weeks, and 18 weeks. The point estimates and 95% confidence intervals for the mean change from baseline are shown. A log transformation for time (plus 0.5) was used to form a linear relationship between visual acuity and time. SD = standard deviation; logMAR = logarithm of the minimum angle of resolution; A = Atropine-only group; A + P = Atropine plus plano lens group.
Figure 3
Figure 3. Cumulative Distribution of Amblyopic Eye Visual Acuity Scores at the 18-Week Outcome Examination According to Treatment Group
Cumulative distribution of amblyopic eye visual acuity scores at 18-week outcome exam according to treatment group.
See this image and copyright information in PMC

References

    1. Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002;120(3):268–78. - PubMed
    1. Pediatric Eye Disease Investigator Group. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol. 2003;121(11):1625–32. - PubMed
    1. Pediatric Eye Disease Investigator Group. A randomized trial of atropine regimens for treatment of moderate amblyopia in children. Ophthalmology. 2004;111(11):2076–85. - PubMed
    1. Kaye SB, Chen SI, Price G, et al. Combined optical and atropine penalization for the treatment of strabismic and anisometropic amblyopia. J AAPOS. 2002;6:289–93. - PubMed
    1. Morrison DG, Palmer NJ, Sinatra RB, Donahue S. Severe amblyopia of the sound eye resulting from atropine therapy combined with optical penalization. J Pediatr Ophthalmol Strabismus. 2005;42(1):52–3. - PubMed

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