Dataset Information

A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years.

ABSTRACT:

Purpose

To determine whether performing near activities while patching for amblyopia enhances improvement in visual acuity.

Design

Randomized clinical trial.

Participants

A total of 425 children, aged 3 to <7 years, with amblyopia (20/40-20/400) that was caused by anisometropia, strabismus, or both, and that persisted after treatment with spectacles.

Methods

Children were randomized to 2 hours of patching per day with near activities or 2 hours of patching per day with distance activities. Instruction sheets describing common near and distance activities were given to the parents. Study visits were scheduled at 2, 5, 8, and 17 weeks. In weeks without a visit, weekly telephone calls were made to the parent to monitor and encourage compliance during the first 8 weeks.

Main outcome measure

Masked assessment of visual acuity by isolated crowded HOTV optotypes at 8 weeks.

Results

At 8 weeks, improvement in amblyopic eye visual acuity averaged 2.6 lines in the distance activities group and 2.5 lines in the near activities group (mean difference in acuity between groups, adjusted for baseline acuity, 0.0 lines 95% confidence interval, -0.3 to 0.3). The 2 groups also appeared statistically similar at the 2-, 5-, and 17-week visits. At the 17-week examination, children with severe amblyopia improved a mean of 3.6 lines with 2 hours of daily patching.

Conclusions

Performing common near activities does not improve visual acuity outcome when treating anisometropic, strabismic, or combined amblyopia with 2 hours of daily patching. Children with severe amblyopia may respond to 2 hours of daily patching.

SUBMITTER: Pediatric Eye Disease Investigator Group

PROVIDER: S-EPMC2615691 | biostudies-literature | 2008 Nov

REPOSITORIES: biostudies-literature

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Publications

A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years.

Ophthalmology 20080911 11

<h4>Purpose</h4>To determine whether performing near activities while patching for amblyopia enhances improvement in visual acuity.<h4>Design</h4>Randomized clinical trial.<h4>Participants</h4>A total of 425 children, aged 3 to <7 years, with amblyopia (20/40-20/400) that was caused by anisometropia, strabismus, or both, and that persisted after treatment with spectacles.<h4>Methods</h4>Children were randomized to 2 hours of patching per day with near activities or 2 hours of patching per day wi ...[more]

PMID: 18789533

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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: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:PurposeDichoptic training is becoming a popular tool in amblyopia treatment. Here we investigated the effects of dichoptic demasking training in children with amblyopia who never received patching treatment (NPT group) or were no longer responsive to patching (PT group).MethodsFourteen NPT and thirteen PT amblyopes (6-16.5 years; 24 anisometropic, two strabismus, and one mixed) received dichoptic demasking training for 17 to 22 sessions. They used the amblyopic eye (AE) to practice contrast discrimination between a pair of Gabors that were dichoptically masked by a band-filtered noise pattern simultaneously presented in the fellow eye (FE). Dichoptic learning was quantified by the increase of maximal tolerable noise contrast (TNC) for AE contrast discrimination. Computerized visual acuities and contrast sensitivity functions for both eyes and the Randot stereoacuity were measured before and after training.ResultsTraining improved maximal TNC by six to eight times in both groups, along with a boost of AE acuities by 0.15 logMAR (P < 0.001) in the NPT group and 0.06 logMAR (P < 0.001) in the PT group. This visual acuity improvement was significantly dependent on the pretraining acuity. Stereoacuity was significantly improved by 41.6% (P = 0.002) in the NPT group and 64.2% (P < 0.001) in the PT group. The stereoacuity gain was correlated to the pretraining interocular acuity difference (r = -0.49, P = 0.010), but not to the interocular acuity difference change (r = -0.28, P = 0.15). Training improved AE contrast sensitivity in the NPT group (P = 0.009) but not the PT group (P = 0.76). Moreover, the learning effects in 12 retested observers were retained for 10 to 24 months.ConclusionsDichoptic training can improve, and sometimes even restore, the stereoacuity of amblyopic children, especially those with mild amblyopia (amblyopic VA ≦0.28 logMAR). The dissociation of stereoacuity gain and the interocular acuity difference change suggests that the stereoacuity gain may not result from a reduced interocular suppression in most amblyopes. Rather, the amblyopes may have learned to attend to, or readout, the stimulus information to improve stereopsis.

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.

Dataset Information

A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years.

Purpose

Design

Participants

Methods

Main outcome measure

Results

Conclusions

Publications

A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years.

Similar Datasets

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