A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years
A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years
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DOI：
10.1016/j.ophtha.2018.10.032
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发表时间：
2019-03-01
期刊：
影响因子：
13.7
通讯作者：
Wallace, David K.
中科院分区：
文献类型：
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作者：
Holmes, Jonathan M.;Manny, Ruth E.;Wallace, David K.
目的：比较7 - 12岁弱视儿童双眼iPad游戏加持续眼镜矫正与单独持续眼镜矫正的视力（VA）改善。设计：多中心随机临床试验。参与者：138名7 - 12岁弱视（33-72个字母，即，约20/200至20/40）。如果需要，参与者需要进行至少16周的眼镜光学治疗，或者在入组前至少8周弱视眼视力（VA）没有改善。合资格参与者（平均年龄9.6岁，平均基线VA为59.6个字母，96%有除眼镜外的弱视治疗史）被随机分配到分视双眼Dig Rush iPad游戏治疗8周（规定每周5天每天1小时）加眼镜配戴（n = 69）或继续单独眼镜矫正（n = 69）。主要结果测量：弱视眼VA从基线到4周的变化，由一名不知情的检查者评估。第4周时，平均弱视眼VA字母评分较基线改善1.3（双侧95%置信区间[CI]：0.1-2.6; 0.026 logMAR）和1.7（双侧95% CI：0.4-3.0; 0.034 logMAR）。调整基线视力后，两组之间的字母评分差异（双眼减去对照）为-0.3（95% CI：-2.2至1.5，P = 0.71，差异为-0.006 logMAR）。治疗8周后重复分析时，未观察到组间字母评分差异（校正均值：-0.1，98.3%CI：-2.4至2.1）。对于双眼组，来自iPad的依从性数据表明，略多于一半的参与者（58%和56%）分别在4周和8周访视时完成了>75%的处方治疗。在既往接受过除眼镜以外的弱视治疗的7至12岁儿童中，用双视双眼Dig Rush iPad游戏治疗4周或8周对VA或立体视觉没有益处。(C)2018年美国眼科学会
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. (C) 2018 by the American Academy of Ophthalmology