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. OBJECTIVE To 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. INTERVENTIONS Binocular iPad game or patching of the fellow eye.MAIN OUTCOMES AND MEASURES Change 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 REGISTRATION http://www.clinicaltrials.gov Identifier: NCT02200211

In teenagers aged 13 to <17 years, improvement in amblyopic eye VA with the binocular iPad game used in this study was not found to be better than patching, and was possibly worse. Nevertheless, it remains unclear whether the minimal treatment response to binocular treatment was owing to poor treatment adherence or lack of treatment effect.

Purpose To determine factors associated with pretreatment and posttreatment stereoacuity in subjects with moderate anisometropic amblyopia. Methods Data for subjects enrolled in seven studies conducted by the Pediatric Eye Disease Investigator Group were pooled. The sample included 633 subjects aged 3 to <18 years with anisometropic amblyopia, no heterotropia observed by cover test, and baseline amblyopic eye acuity of 20/100 or better. A subset included 248 subjects who were treated with patching or Bangerter filters and had baseline stereoacuity testing and outcome examinations. Multivariate regression models identified factors associated with baseline stereoacuity and with outcome stereoacuity as measured by the Randot Preschool Stereoacuity test. Results Better baseline stereoacuity was associated with better baseline amblyopic eye acuity (P < 0.001), less anisometropia (P = 0.03), and anisometropia due to astigmatism alone (P < 0.001). Better outcome stereoacuity was associated with better baseline stereoacuity (P < 0.001) and better amblyopic eye acuity at outcome (P < 0.001). Among 48 subjects whose amblyopic eye visual acuity at outcome was 20/25 or better and within one line of the fellow eye, stereoacuity was worse than that of children with normal vision of the same age. Conclusions In children with anisometropic amblyopia of 20/40 to 20/100 inclusive, better posttreatment stereoacuity is associated with better baseline stereoacuity and better posttreatment amblyopic eye acuity. Even if their visual acuity deficit resolves, many children with anisometropic amblyopia have stereoacuity worse than that of nonamblyopic children of the same age.

Purpose: To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad ® game plus continued spectacle correction versus continued spectacle correction alone.

Objective After treatment with refractive correction and patching, some patients have residual amblyopia resulting from strabismus or anisometropia. We conducted a clinical trial to evaluate the effectiveness of increasing prescribed daily patching from 2 to 6 hours in children with stable residual amblyopia. Design Prospective, randomized, multicenter clinical trial. Participants A total of 169 children aged 3 to <8 years (mean, 5.9 years) with stable residual amblyopia (20/32–20/160) after 2 hours of daily patching for at least 12 weeks. Intervention Random assignment to continue 2 hours of daily patching or increase patching time to an average of 6 hours/day. Main Outcome Measures Best-corrected visual acuity (VA) in the amblyopic eye after 10 weeks. Results Baseline VA was 0.44 logarithm of the minimum angle of resolution (logMAR) (20/50−2). Ten weeks after randomization, amblyopic eye VA had improved an average of 1.2 lines in the 6-hour group and 0.5 line in the 2-hour group (difference in mean VA adjusted for acuity at randomization = 0.6 line; 95% confidence interval, 0.3–1.0; P = 0.002). Improvement of 2 or more lines occurred in 40% of participants patched for 6 hours versus 18% of those who continued to patch for 2 hours (P = 0.003). Conclusions When amblyopic eye VA stops improving with 2 hours of daily patching, increasing the daily patching dosage to 6 hours results in more improvement in VA after 10 weeks compared with continuing 2 hours daily.