Patching vs Atropine to Treat Amblyopia in Children Aged 7 to 12 Years A Randomized Trial

Patching vs Atropine to Treat Amblyopia in Children Aged 7 to 12 Years A Randomized Trial
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DOI:
10.1001/archophthalmol.2008.107
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发表时间:
2008-12-01
影响因子:
--
通讯作者:
Tamkins, Susanna M.
Tamkins, Susanna M.
中科院分区:
其他
文献类型:
--
作者:
Scheiman, Mitchell M.;Hertle, Richard W.;Tamkins, Susanna M.

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目的:比较阿托品滴眼液和阿托品滴眼液对7~12岁儿童中度弱视(视力20/40~20/100)的治疗效果。方法:采用随机、多中心临床试验方法,将193例弱视儿童随机分成两组,分别接受周末阿托品治疗和听觉眼部修补2小时。主要观察指标:弱视儿童弱视17周后,采用电子早期治疗糖尿病视网膜病变研究测试方案进行掩蔽视力评估。结果:17周后,阿托品组视力较治疗前平均提高7.6个字母,戴片组平均提高8.6个字母。根据基线视力调整后,两组(补片-阿托品)之间的平均差异为1.2个字母(非劣势互补单侧95%可信区间的末端,-0.7,3.1个字母)。此差异满足预先指定的等价性定义(置信度区间
Objective: To compare patching with atropine eyedrops in the treatment of moderate amblyopia (visual acuity, 20/40-20/100) in children aged 7 to 12 years.Methods: In a randomized, multicenter clinical trial, 193 children with amblyopia were assigned to receive weekend atropine or patching of the sound eye 2 hours per day.Main Outcome Measure: Masked assessment of visual acuity in the amblyopic eye using the electronic Early Treatment Diabetic Retinopathy Study testing protocol at 17 weeks.Results: At 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group. The mean difference between groups (patching - atropine) adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority, -0.7, 3.1 letters). This difference met the prespecified definition for equivalence (confidence interval