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

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

SUBMITTER: Pediatric Eye Disease Investigator Group

PROVIDER: S-EPMC2713107 | biostudies-literature | 2009 Jan

REPOSITORIES: biostudies-literature

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

Archives of ophthalmology (Chicago, Ill. : 1960) 20090101 1

<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Main outcome measure</h4>Masked assessment of amblyopic eye visual acuity ...[more]

PMID: 19139333

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Project description:BackgroundAmblyopia is defined as defective visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing glasses.ObjectivesTo assess the effectiveness and safety of conventional occlusion versus atropine penalization for amblyopia.Search strategyWe searched CENTRAL, MEDLINE, EMBASE, LILACS, the WHO International Clinical Trials Registry Platform, preference lists, science citation index and ongoing trials up to June 2009.Selection criteriaWe included randomized/quasi-randomized controlled trials comparing conventional occlusion to atropine penalization for amblyopia.Data collection and analysisTwo authors independently screened abstracts and full text articles, abstracted data, and assessed the risk of bias.Main resultsThree trials with a total of 525 amblyopic eyes were included. One trial was assessed as having a low risk of bias among these three trials, and one was assessed as having a high risk of bias.Evidence from three trials suggests atropine penalization is as effective as conventional occlusion. One trial found similar improvement in vision at six and 24 months. At six months, visual acuity in the amblyopic eye improved from baseline 3.16 lines in the occlusion and 2.84 lines in the atropine group (mean difference 0.034 logMAR; 95% confidence interval (CI) 0.005 to 0.064 logMAR). At 24 months, additional improvement was seen in both groups; but there continued to be no meaningful difference (mean difference 0.01 logMAR; 95% CI -0.02 to 0.04 logMAR). The second trial reported atropine to be more effective than occlusion. At six months, visual acuity improved 1.8 lines in the patching group and 3.4 lines in the atropine penalization group, and was in favor of atropine (mean difference -0.16 logMAR; 95% CI -0.23 to -0.09 logMAR). Different occlusion modalities were used in these two trials. The third trial had inherent methodological flaws and limited inference could be drawn.No difference in ocular alignment, stereo acuity and sound eye visual acuity between occlusion and atropine penalization was found. Although both treatments were well tolerated, compliance was better in atropine. Atropine penalization costs less than conventional occlusion. The results indicate that atropine penalization is as effective as conventional occlusion.Authors' conclusionsBoth conventional occlusion and atropine penalization produce visual acuity improvement in the amblyopic eye. Atropine penalization appears to be as effective as conventional occlusion, although the magnitude of improvement differed among the three trials. Atropine penalization can be used as first line treatment for amblyopia.

Dataset Information

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

Publications

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

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