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Comparison between patching and interactive binocular treatment in amblyopia: A randomized clinical trial.

ABSTRACT: Purpose:To compare the effect of amblyopia therapy on cases who received interactive binocular treatment (I-BiT™) with those who received standard patching of the dominant eye with placebo I-BiT™. Methods:In this randomized clinical trial, 38 unilateral amblyopic children (3-10 years old) were studied. All unilateral amblyopic children who had best corrected visual acuity (BCVA) worse than 0.30 logMAR or a difference of two Snellen lines of BCVA between their two eyes were included, and children who did not complete at least 75% of amblyopia treatment were excluded from this study. Eventually, a total of 19 and 21 subjects were included in case and control groups, respectively. Cases played I-BiT™ games, while controls had standard patch therapy and played with placebo I-BiT™ games, both for one month. All subjects were examined at baseline and after one-month therapy. Results:BCVA improved significantly in both groups after one-month treatment (case: P = 0.003, control: P < 0.001), while in comparison with each other, there was not any difference between them (P = 0.52). Although stereopsis improved in the case (P < 0.001) and control (P < 0.001), there was no significant difference between them pre and post-therapy. Our children played games for about 6 h total during one month in both groups, and their compliance was 87.5% and 76% in cases and controls, respectively. Two children were excluded due to their lower compliance of playing I-BiT™ games (n = 38). Conclusions:I-BiT™ game and patching with placebo game had similar BCVA improvement in amblyopic children after one-month treatment. It is suggested to conduct further randomized clinical trials with a larger sample size and longer duration of study and assessment of its recurrence.

SUBMITTER: Rajavi Z

PROVIDER: S-EPMC6896467 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Comparison between patching and interactive binocular treatment in amblyopia: A randomized clinical trial.

Rajavi Zhale Z Sabbaghi Hamideh H Amini Sharifi Ebrahim E Behradfar Narges N Kheiri Bahareh B

Journal of current ophthalmology 20190814 4

<h4>Purpose</h4>To compare the effect of amblyopia therapy on cases who received interactive binocular treatment (I-BiT™) with those who received standard patching of the dominant eye with placebo I-BiT™.<h4>Methods</h4>In this randomized clinical trial, 38 unilateral amblyopic children (3-10 years old) were studied. All unilateral amblyopic children who had best corrected visual acuity (BCVA) worse than 0.30 logMAR or a difference of two Snellen lines of BCVA between their two eyes were include ...[more]

PMID: 31844795

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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.

Project description:ObjectivesTo compare visual outcome in response to two prescribed rates of occlusion (six hours a day and 12 hours a day).DesignUnmasked randomised trial.SettingResearch clinics in two London hospitals.Participants97 children with a confirmed diagnosis of amblyopia associated with strabismus, anisometropia, or both.Interventions18 week period of wearing glasses (refractive adaptation) followed by occlusion prescribed ("patching") for six or 12 hours a day.Main outcome measuresVisual acuity measured by logMAR letter recognition; objectively monitored rate of occlusion (hours a day).ResultsThe mean age of children at study entry was 5.6 (SD 1.5) years. Ninety were eligible for occlusion but 10 dropped out in this phase, leaving 80 children who were randomised to a prescribed dose rate of six (n=40) or 12 (n=40) hours a day. The mean change in visual acuity of the amblyopic eye was not significantly different (P=0.64) between the two groups (0.26 (95% confidence interval 0.21 to 0.31) log units in six hour group; 0.24 (0.19 to 0.29) log units in 12 hour group). The mean dose rates (hours a day) actually received, however, were also not significantly different (4.2 (3.7 to 4.7) in six hour group v 6.2 (5.1 to 7.3) in 12 hour group; P=0.06). The visual outcome was similar for those children who received three to six hours a day or more than six to 12 hours a day, but significantly better than that in children who received less than three hours a day. Children aged under 4 required significantly less occlusion than older children. Visual outcome was not influenced by type of amblyopia.ConclusionsSubstantial (six hours a day) and maximal (12 hours a day) prescribed occlusion results in similar visual outcome. On average, the occlusion dose received in the maximal group was only 50% more than in the substantial group and in both groups was much less than that prescribed. Younger children required the least occlusion.Trials registrationClinical Trials NCT00274664.

Dataset Information

Comparison between patching and interactive binocular treatment in amblyopia: A randomized clinical trial.

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Comparison between patching and interactive binocular treatment in amblyopia: A randomized clinical trial.

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