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Clinical Trials |

Pharmacological Plus Optical Penalization Treatment for Amblyopia:  Results of a Randomized Trial

Arch Ophthalmol. 2009;127(1):22-30. doi:10.1001/archophthalmol.2008.520.
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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.gov Identifier: NCT00315302

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Figure 1.

Flowchart showing study completion in each treatment group. Atropine was given as atropine sulfate.

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Figure 2.

Improvement in 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. For the interaction term between time and treatment group, P = .10. Atropine was given as atropine sulfate.

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Figure 3.

Cumulative distribution of amblyopic eye visual acuity scores at the 18-week outcome examination according to treatment group. Atropine was given as atropine sulfate.

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