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 vs. continued spectacle correction alone. DESIGN Multicenter randomized clinical trial. PARTICIPANTS One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33-72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. METHODS Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). MAIN OUTCOME MEASURES Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. RESULTS At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1-2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4-3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. CONCLUSIONS In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.

中文翻译：

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对7至12岁儿童进行弱视的双眼Dig Rush游戏治疗的随机试验。

目的比较双眼iPad游戏加持续眼镜矫正与单独持续眼镜矫正治疗的弱视7至12岁儿童的视力（VA）改善情况。设计多中心随机临床试验。参与者138名年龄在7至12岁之间的患有斜视，屈光参差或两者兼有的弱视（33-72个字母，即大约20/200至20/40）的参与者。如果需要，参加者必须在眼镜上进行至少16周的光学治疗，或者入组前至少8周的弱视眼视力（VA）没有任何改善。方法：符合条件的参与者（平均年龄9.6岁，平均基线VA为59.6个字母，曾有过除眼镜以外的弱视治疗史（有96％）被随机分配为使用双眼双眼Dig Rush iPad游戏（规定为每天1小时，每周5天，每天8小时）治疗8周（n = 69）或仅在需要时单独进行眼镜矫正（n = 69）。主要观察指标由一名戴着口罩的检查员评估弱视眼VA从基线到4周的变化。结果在第4周，双眼治疗的弱视眼VA字母平均得分较基线提高了1.3（2-侧95％置信区间[CI]：0.1-2.6； 0.026 logMAR），而双眼则提高了1.7（2-侧95％CI： 0.4-3.0; 0.034 logMAR），且仅需继续进行眼镜矫正。在确定基线VA后，各组（双眼减去对照组）的字母得分差异为-0.3（95％CI：-2.2至1.5，P = 0.71，差异为-0.006 logMAR）。在治疗8周后重复进行分析时，两组之间的字母得分没有差异（调整后的平均值：-0.1，98.3％CI：-2.4至2.1）。对于双眼组，iPad的依从性数据表明，分别有略多于一半的参与者（58％和56％）分别在4周和8周就诊时完成了超过75％的处方治疗。结论在接受眼镜以外的弱视治疗的7至12岁儿童中，使用两眼双眼Dig Rush iPad游戏治疗4周或8周对VA或立体视没有益处。iPad的依从性数据表明，分别在4周和8周的访问中，略多于一半的参与者（58％和56％）完成了超过75％的处方治疗。结论在接受眼镜以外的弱视治疗的7至12岁儿童中，使用双眼双眼Dig Rush iPad游戏治疗4周或8周对VA或立体视没有益处。iPad的依从性数据表明，在4周和8周的访问中，略多于一半的参与者（58％和56％）分别完成了超过75％的处方治疗。结论在接受眼镜以外的弱视治疗的7至12岁儿童中，使用两眼双眼Dig Rush iPad游戏治疗4周或8周对VA或立体视没有益处。