Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
University of Houston College of Optometry, Houston, Texas.
Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22.
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.
Multicenter randomized clinical trial.
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.
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).
Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner.
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.
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.
比较 7 至 12 岁弱视儿童在使用双眼 iPad 游戏加持续眼镜矫正与单纯持续眼镜矫正治疗后视力（VA）的改善情况。
多中心随机临床试验。
138 名 7 至 12 岁的弱视儿童（33-72 个字母，即大约 20/200 至 20/40），病因包括斜视、屈光参差或两者兼有。参与者需要在眼镜中进行至少 16 周的光学治疗，如果需要，或者在入组前至少 8 周内弱视眼视力（VA）无改善。
符合条件的参与者（平均年龄 9.6 岁，基线 VA 平均为 59.6 个字母，既往除眼镜外接受过弱视治疗的占 96%）被随机分为 8 周的治疗组，使用双眼 Dig Rush iPad 游戏（每天 5 天，每天 1 小时，规定）加需要时的眼镜佩戴（n=69）或单纯需要时的持续眼镜矫正（n=69）。
由盲法评估员评估从基线到 4 周时弱视眼 VA 的变化。
在 4 周时，与单独使用眼镜矫正相比，双眼治疗组弱视眼的 VA 字母评分从基线提高了 1.3（双侧 95%置信区间[CI]：0.1-2.6；0.026 对数最小分辨差），单独使用眼镜矫正提高了 1.7（双侧 95%CI：0.4-3.0；0.034 对数最小分辨差）。调整基线 VA 后，两组间的字母评分差值（双眼治疗组减去对照组）为-0.3（双侧 95%CI：-2.2 至 1.5，P=0.71，差值为-0.006 对数最小分辨差）。治疗 8 周后，当分析重复时，两组间的字母评分无差异（调整后的平均值：-0.1，98.3%CI：-2.4 至 2.1）。对于双眼治疗组，来自 iPad 的依从性数据表明，略超过一半的参与者（58%和 56%）分别在第 4 周和第 8 周的就诊时完成了>75%的规定治疗。
在接受过除眼镜以外的弱视治疗的 7 至 12 岁儿童中，使用双眼 Dig Rush iPad 游戏治疗 4 或 8 周并不能提高视力或立体视锐度。
