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Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial.

ABSTRACT: Initial 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.To 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.In 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.Initial treatment with patching or atropine with subsequent treatment at investigator discretion.Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes.Mean 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?

SUBMITTER: Repka MX

PROVIDER: S-EPMC4206086 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial.

Repka Michael X MX Kraker Raymond T RT Holmes Jonathan M JM Summers Allison I AI Glaser Stephen R SR Barnhardt Carmen N CN Tien David R DR

JAMA ophthalmology 20140701 7

<h4>Importance</h4>Initial 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.<h4>Objective</h4>To 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.<h4>Design, setting, and participants</h4>In a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100 ...[more]

PMID: 24789375

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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:Importance:Fellow eye patching has long been the standard treatment for amblyopia, but it does not always restore 20/20 vision or teach the eyes to work together. Amblyopia can be treated with binocular games that rebalance contrast between the eyes so that a child may overcome suppression. However, it is unclear whether binocular treatment is comparable to patching in treating amblyopia. Objectives:To assess the effectiveness of a binocular iPad (Apple Inc) adventure game as amblyopia treatment and compare this binocular treatment with patching, the current standard of care. Design, Setting, and Participants:This investigation was a randomized clinical trial with a crossover design at a nonprofit eye research institute. Between February 20, 2015, and January 4, 2016, a total of 28 patients were enrolled in the study, with 14 randomized to binocular game treatment and 14 to patching treatment. Interventions:Binocular game and patching as amblyopia treatments. Main Outcomes and Measures:The primary outcome was change in amblyopic eye best-corrected visual acuity (BCVA) at the 2-week visit. Secondary outcomes were change in stereoacuity and suppression at the 2-week visit and change in BCVA at the 4-week visit. Results:Among 28 children, the mean (SD) age at baseline was 6.7 (1.4) years (age range, 4.6-9.5 years), and 7 (25%) were female. At baseline, the mean (SD) amblyopic eye BCVA was 0.48 (0.14) logMAR (approximately 20/63; range, 0.3-0.8 logMAR [20/40 to 20/125]), with 14 children randomized to the binocular game and 14 to patching for 2 weeks. At the 2-week visit, improvement in amblyopic eye BCVA was greater with the binocular game compared with patching, with a mean (SD) improvement of 0.15 (0.08) logMAR (mean [SD], 1.5 [0.8] lines) vs 0.07 (0.08) logMAR (mean [SD], 0.7 [0.8] line; P?=?.02) after 2 weeks of treatment. These improvements from baseline were significant for the binocular game (mean [SD] improvement, 1.5 [0.8] lines; P?<?.001) and for patching (mean [SD] improvement, 0.7 [0.8] line; P?=?.006). Depth of suppression improved from baseline at the 2-week visit for the binocular game (mean [SD], 4.82 [2.82] vs 3.24 [2.87]; P?=?.03) and for patching (mean [SD], 4.77 [3.10] vs 2.57 [1.67]; P?=?.004). Patching children crossed over to binocular game treatment, and all 28 children played the game for another 2 weeks. At the 4-week visit, no group difference was found in BCVA change, with children who crossed over to the binocular games catching up with children treated with binocular games, for a mean (SD) improvement of 0.17 (0.10) logMAR (mean [SD], 1.7 [1.0] lines) for the binocular game vs a mean (SD) improvement of 0.16 (0.12) logMAR (mean [SD], 1.6 [1.2] lines) for the patching crossover (P?=?.73). Conclusions and Relevance:A binocular iPad game was effective in treating childhood amblyopia and was more efficacious than patching at the 2-week visit. Binocular games that rebalance contrast to overcome suppression are a promising additional option for treating amblyopia. Trial Registration:clinicaltrials.gov Identifier: NCT02365090.

Project description:ImportanceA binocular approach to treating anisometropic and strabismic amblyopia has recently been advocated. Initial studies have yielded promising results, suggesting that a larger randomized clinical trial is warranted.ObjectiveTo compare visual acuity (VA) improvement in children with amblyopia treated with a binocular iPad game vs part-time patching.Design, setting, and participantsA multicenter, noninferiority randomized clinical trial was conducted in community and institutional practices from September 16, 2014, to August 28, 2015. Participants included 385 children aged 5 years to younger than 13 years with amblyopia (20/40 to 20/200, mean 20/63) resulting from strabismus, anisometropia, or both. Participants were randomly assigned to either 16 weeks of a binocular iPad game prescribed for 1 hour a day (190 participants; binocular group) or patching of the fellow eye prescribed for 2 hours a day (195 participants; patching group). Study follow-up visits were scheduled at 4, 8, 12, and 16 weeks. A modified intent-to-treat analysis was performed on participants who completed the 16-week trial.InterventionsBinocular iPad game or patching of the fellow eye.Main outcomes and measuresChange in amblyopic-eye VA from baseline to 16 weeks.ResultsOf the 385 participants, 187 were female (48.6%); mean (SD) age was 8.5 (1.9) years. At 16 weeks, mean amblyopic-eye VA improved 1.05 lines (2-sided 95% CI, 0.85-1.24 lines) in the binocular group and 1.35 lines (2-sided 95% CI, 1.17-1.54 lines) in the patching group, with an adjusted treatment group difference of 0.31 lines favoring patching (upper limit of the 1-sided 95% CI, 0.53 lines). This upper limit exceeded the prespecified noninferiority limit of 0.5 lines. Only 39 of the 176 participants (22.2%) randomized to the binocular game and with log file data available performed more than 75% of the prescribed treatment (median, 46%; interquartile range, 20%-72%). In younger participants (aged 5 to <7 years) without prior amblyopia treatment, amblyopic-eye VA improved by a mean (SD) of 2.5 (1.5) lines in the binocular group and 2.8 (0.8) lines in the patching group. Adverse effects (including diplopia) were uncommon and of similar frequency between groups.Conclusions and relevanceIn children aged 5 to younger than 13 years, amblyopic-eye VA improved with binocular game play and with patching, particularly in younger children (age 5 to <7 years) without prior amblyopia treatment. Although the primary noninferiority analysis was indeterminate, a post hoc analysis suggested that VA improvement with this particular binocular iPad treatment was not as good as with 2 hours of prescribed daily patching.Trial registrationhttp://www.clinicaltrials.gov Identifier: NCT02200211.

Dataset Information

Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial.

Publications

Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial.

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