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Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials.

ABSTRACT: To determine the effectiveness of weekend atropine for severe amblyopia from strabismus, anisometropia, or both combined among children 3 to 12 years of age.We enrolled children into 2 prospective, randomized multicenter clinical trials of amblyopia therapy. Herein we report the results for severe amblyopia, 20/125 to 20/400. In Trial 1, 60 children 3 to 6 years of age (mean, 4.4 years) were randomized to weekend atropine plus a plano lens or weekend atropine plus full spectacle correction for the sound eye. In Trial 2, 40 children 7 to 12 years of age (mean, 9.3 years) were randomized to weekend atropine or 2 hours of daily patching. The visual acuity outcome was assessed at 18 weeks in Trial 1 and 17 weeks in Trial 2.In Trial 1, visual acuity improved by an average of 4.5 lines in the atropine plus correction group (95% CI, 3.2-5.8 lines) and 5.1 lines in the atropine plus plano lens group (95% CI, 3.7-6.4 lines). In Trial 2, visual acuity improved by an average of 1.5 lines in the atropine group (95% CI, 0.5-2.5 lines) and 1.8 lines in the patching group (95% CI, 1.1-2.6 lines).Weekend atropine can improve visual acuity in children 3 to 12 years of age with severe amblyopia. Improvement may be greater in younger children.

SUBMITTER: Repka MX

PROVIDER: S-EPMC2713117 | biostudies-literature | 2009 Jun

REPOSITORIES: biostudies-literature

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Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials.

Repka Michael X MX Kraker Raymond T RT Beck Roy W RW Birch Eileen E Cotter Susan A SA Holmes Jonathan M JM Hertle Richard W RW Hoover Darren L DL Klimek Deborah L DL Marsh-Tootle Wendy W Scheiman Mitchell M MM Suh Donny W DW Weakley David R DR

Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus 20090601 3

<h4>Purpose</h4>To determine the effectiveness of weekend atropine for severe amblyopia from strabismus, anisometropia, or both combined among children 3 to 12 years of age.<h4>Methods</h4>We enrolled children into 2 prospective, randomized multicenter clinical trials of amblyopia therapy. Herein we report the results for severe amblyopia, 20/125 to 20/400. In Trial 1, 60 children 3 to 6 years of age (mean, 4.4 years) were randomized to weekend atropine plus a plano lens or weekend atropine plus ...[more]

PMID: 19541265

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Project description:ImportancePatching is often less effective for severe amblyopia because of poor adherence. For the treatment of severe amblyopia, although combined atropine and patching therapy (CAPT) has been found to be efficacious, it is currently unknown whether CAPT is more efficacious than patching alone.ObjectiveTo compare the efficacy of CAPT vs patching alone in children aged 3 to 12 years with severe amblyopia.Design, setting, and participantsThis single-center randomized clinical trial was conducted from November 2018 to May 2020. The visual acuity (VA) examiner was masked to the treatment groups. The follow-up visits were at 3 months and 6 months. Participants aged 3 to 12 years with severe amblyopia (20/100 to 20/500) resulting from strabismus, anisometropia, or both were randomly assigned to CAPT or patching therapy.InterventionsCAPT or patching alone for 6 months.Main outcomes and measuresChange of the amblyopic eye VA from baseline to 6 months.ResultsAmong 108 participants, the mean (SD) age was 5.2 (1.8) years, and 54 (50%) were female. Overall, 53 participants (49%) were randomized to CAPT and 55 (51%) were randomized to patching therapy. At baseline, the mean (SD) amblyopic eye VA was 0.95 (0.22) logMAR (approximately 20/200 [2.2 lines]). At 6 months, the CAPT group's mean improvement in amblyopic eye VA was 0.72 logMAR (7.2 lines) compared with 0.58 logMAR (5.8 lines) in the patching alone group (difference, 0.14 logMAR [1.4 lines] greater in the CAPT group; 95% CI, 0.05-0.22 logMAR [0.5-2.2 lines]; P = .002). The amblyopic eye VA improvement in the CAPT group also was greater than that in the patching alone group at 3 months (difference in the means, 0.13 logMAR [1.3 lines]; 95% CI, 0.04-0.22 logMAR [0.4-2.2 lines]; P = .004). No participants were withdrawn because of adverse effects.Conclusions and relevanceCAPT resulted in more mean improvement of amblyopic eye VA than patching alone among participants enrolled in this trial, although the clinical relevance of this relatively small VA difference cannot be determined from this trial.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR1800018663.

Project description:ImportanceInitial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity. Long-term data on the durability of treatment benefit are needed.ObjectiveTo report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia.Design, setting, and participantsIn a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100) were randomly assigned to patching (minimum of 6 h/d) or atropine sulfate eyedrops, 1% (1 drop daily), for 6 months. Treatment after 6 months was at the discretion of the investigator. Two years after enrollment, an unselected subgroup of 188 children were enrolled into long-term follow-up.InterventionInitial treatment with patching or atropine with subsequent treatment at investigator discretion.Main outcomes and measuresVisual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes.ResultsMean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR (approximately 20/25); 59.9% of amblyopic eyes had visual acuity of 20/25 or better and 33.3%, 20/20 or better. Mean interocular acuity difference (IOD) at 15 years of age was 0.21 logMAR (2.1 lines); 48.3% had an IOD of 2 or more lines and 71.4%, 1 or more lines. Treatment (other than spectacles) was prescribed for 9 participants (6.1%) aged 10 to 15 years. Mean IOD was similar at examinations at 10 and 15 years of age (2.0 and 2.1 logMAR lines, respectively; P = .39). Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial (mean logMAR, 0.09) compared with those aged 5 to 6 years (mean logMAR, 0.18; P < .001). When we compared subgroups based on original treatment with atropine or patching, no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age (P = .44 and P = .43, respectively).Conclusions and relevanceAt 15 years of age, most children treated for moderate amblyopia when younger than 7 years have good visual acuity, although mild residual amblyopia is common. The outcome is similar regardless of initial treatment with atropine or patching. The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age.Trial registrationclinicaltrials.gov Identifier: NCT00000170.

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Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials.

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Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials.

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