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Original Investigation
Journal Club, Clinical Trial
December 2016

Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With AmblyopiaA Randomized Clinical Trial

Journal Club PowerPoint Slide Download
Author Affiliations
  • 1Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota
  • 2Division of Ophthalmology, Seattle Children's Hospital, Seattle, Washington
  • 3Jaeb Center for Health Research, Tampa, Florida
  • 4Deputy editor, JAMA Ophthalmology
  • 5Retina Foundation of the Southwest, Dallas, Texas
  • 6Department of Ophthalmology, Eastern Virginia Medical School, Norfolk
  • 7Department of Surgery, North East Ohio Medical University, Rootstown
  • 8Accent Physicians, Gainesville, Florida
  • 9Department of Ophthalmology, Oregon Health & Science University, Portland
  • 10Department of Ophthalmology, Duke Eye Center, Durham, North Carolina
JAMA Ophthalmol. 2016;134(12):1391-1400. doi:10.1001/jamaophthalmol.2016.4262
Key Points

Question  Is amblyopic-eye visual acuity improvement treated with a binocular iPad game not substantially worse than part-time patching?

Findings  In a noninferiority randomized clinical trial enrolling 385 children, the 16-week mean amblyopic-eye visual acuity improved 1.05 lines in the binocular group and 1.35 lines in the patching group, an adjusted treatment group difference of 0.31 lines favoring patching (upper limit of the 1-sided 95% CI, 0.53 lines, exceeding the prespecified noninferiority limit of 0.5 lines, which is an indeterminate result).

Meaning  This trial cannot establish whether binocular iPad treatment is not substantially worse than 2 hours of prescribed daily patching.

Abstract

Importance  A 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.

Objective  To compare visual acuity (VA) improvement in children with amblyopia treated with a binocular iPad game vs part-time patching.

Design, Setting, and Participants  A 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.

Interventions  Binocular iPad game or patching of the fellow eye.

Main Outcomes and Measures  Change in amblyopic-eye VA from baseline to 16 weeks.

Results  Of 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 Relevance  In 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 Registration  http://www.clinicaltrials.gov Identifier: NCT02200211

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