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A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia

机译:间歇性闭塞疗法液晶玻璃与传统贴片治疗中度单侧弱视的一项随机临床试验

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摘要

PURPOSE:To compare the effectiveness of intermittent occlusion therapy (IO therapy) using liquid crystal glasses and continuous occlusion therapy using traditional adhesive patches for treating amblyopia.METHODS:Children 3-8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled in this randomized controlled trial. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn any optimal refractive correction for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO therapy group with liquid crystal glasses (Amblyz), set at 30-second opaque/transparent intervals (occluded 50% of wear time), and a 2-hour continuous patching group (occluded 100% of wear time). For each patient, visual acuity was measured using ATS-HOTV before and after 12 weeks of treatment.RESULTS:Data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15 ± 0.12 logMAR (95% CI, 0.09-0.15) in the IO therapy group (n = 19) and 0.15 ± 0.11 logMAR (95% CI, 0.1-0.15) in the patching group (n = 15). In both groups improvement was significant, but the difference between groups was not (P = 0.73). No adverse effects were reported.CONCLUSIONS:In this pilot study, IO therapy with liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3-8 years of age with moderate amblyopia.
机译:目的:比较使用液晶玻璃的间歇性闭塞疗法(IO疗法)和使用传统胶粘剂治疗连续性闭塞疗法的弱视效果。方法:3-8岁的儿童,以前未经治疗的中度单侧弱视(视力)这项弱视对照研究纳入了弱视眼的20%至40/20至20/100的受试者)。弱视与斜视,屈光参差或两者兼有。所有受试者至少在12周内没有进行任何最佳的屈光矫正,而没有改善。将受试者随机分为两个治疗组:4小时带液晶玻璃(Amblyz)的IO治疗组,设置为30秒不透明/透明间隔(遮盖佩戴时间的50%)和2小时连续修补组(占用了100%的磨损时间)。对于每位患者,在治疗12周之前和之后均使用ATS-HOTV测量视力。结果:34位患者的数据可供分析。 IO治疗组(n = 19)与基线相比,弱视眼视敏度提高了0.15±0.12 logMAR(95%CI,0.09-0.15),而修补组的弱视眼视力提高了0.15±0.11 logMAR(95%CI,0.1-0.15)( n = 15)。两组均有显着改善,但组间差异无统计学意义(P = 0.73)。结论:在这项初步研究中,使用液晶玻璃进行IO治疗并不逊色于胶粘剂修补,并且是3-8岁中度弱视儿童的有希望的替代治疗方法。

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