A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia.
A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia.
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DOI：
10.1016/j.jaapos.2016.05.014
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发表时间：
2016-08
期刊：
影响因子：
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通讯作者：
Plager DA
中科院分区：
文献类型：
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作者：
Wang J;Neely DE;Galli J;Schliesser J;Graves A;Damarjian TG;Kovarik J;Bowsher J;Smith HA;Donaldson D;Haider KM;Roberts GJ;Sprunger DT;Plager DA
这项初步研究旨在比较使用液晶眼镜的间歇性遮盖疗法（IO疗法）与使用传统贴片的连续性遮盖疗法治疗弱视的有效性。一项随机对照试验。入组3-8岁既往未经治疗的中度单侧弱视儿童（弱视眼的视力为20/40至20/100）。弱视与斜视、屈光参差或两者相关。所有受试者均配戴最佳屈光矫正（如需要）至少12周，无改善。受试者被随机分为两个治疗组：4小时IO-Therapy组，使用液晶眼镜（Amblyz™），设置为30秒不透明/透明间隔（遮挡50%的佩戴时间）或2小时连续修补组（遮挡100%的佩戴时间）。在治疗前和治疗12周后，用ATS-HOTV方法测量每例患者的视力。在前12周治疗间隔结束时，34例患者的数据可用于分析。IO治疗组（N=19）弱视眼视力较基线改善为0.15±0.12（95%CI =0.09至0.15）logMAR，贴片组（N= 15）为0.15±0.11（95%CI =0.1至0.15）logMAR。两组的改善都很显著。组间差异无统计学意义（P=0.73）。未报告不良反应。在这项试点研究中，Amblyz液晶眼镜的IO-Therapy并不亚于粘合剂贴片，是3-8岁中度弱视儿童的一种有前途的替代治疗方法。未来需要更大规模的随机临床试验来证实结果。
This pilot study was designed to compare the effectiveness of intermittent occlusion therapy (IO-Therapy) using liquid crystal glasses versus continuous occlusion therapy using traditional adhesive patches for treating amblyopia. A randomized controlled trial. 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. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn optimal refractive correction (if needed) 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) or a 2-hour continuous Patching Group (occluded 100% of wear time). For each patient, visual acuity was measured with the ATS-HOTV method before and after 12 weeks of treatment. At the conclusion of the first 12 week-treatment interval, data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15±0.12 (95% CI=0.09 to 0.15) logMAR in the IO-Therapy Group (N=19) and 0.15±0.11 (95% CI=0.1 to 0.15) logMAR in the Patching Group (N=15). Improvements in both groups were significant. The difference between groups was not statistically significant (P=0.73). No adverse effects were reported. In this pilot study, IO-Therapy with Amblyz 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. A larger randomized clinical trial is needed to confirm results in future.