Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial.
OBJECTIVE
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.


METHODS
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.


METHODS
Binocular iPad game or patching of the fellow eye.


METHODS
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
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.


BACKGROUND
http://www.clinicaltrials.gov Identifier: NCT02200211.
Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
Jonathan M
JM
Holmes
Division of Ophthalmology, Seattle Children's Hospital, Seattle, Washington.
Vivian M
VM
Manh
Jaeb Center for Health Research, Tampa, Florida.
Elizabeth L
EL
Lazar
Jaeb Center for Health Research, Tampa, Florida4Deputy editor, JAMA Ophthalmology.
Roy W
RW
Beck
Retina Foundation of the Southwest, Dallas, Texas.
Eileen E
EE
Birch
Jaeb Center for Health Research, Tampa, Florida.
Raymond T
RT
Kraker
Department of Ophthalmology, Eastern Virginia Medical School, Norfolk.
Eric R
ER
Crouch
Department of Surgery, North East Ohio Medical University, Rootstown.
S Ayse
SA
Erzurum
Accent Physicians, Gainesville, Florida.
Nausheen
N
Khuddus
Department of Ophthalmology, Oregon Health & Science University, Portland.
Allison I
AI
Summers
Department of Ophthalmology, Duke Eye Center, Durham, North Carolina.
David K
DK
Wallace
D000550:Amblyopia / Q000503:physiopathology / Q000628:therapy*; D001458:Bandages; D002648:Child; D002675:Child, Preschool; D034201:Computers, Handheld; D005139:Eyeglasses; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012683:Sensory Deprivation; D018910:Video Games; D015348:Vision, Binocular / Q000502:physiology*; D014792:Visual Acuity / Q000502:physiology*