Pharmacological Plus Optical Penalization Treatment for Amblyopia Results of a Randomized Trial
Pharmacological Plus Optical Penalization Treatment for Amblyopia Results of a Randomized Trial
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DOI：
10.1001/archophthalmol.2008.520
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发表时间：
2009-01-01
影响因子：
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通讯作者：
Wheeler, David T.
中科院分区：
文献类型：
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作者：
Cotter, Susan A.;Weakley, David R., Jr.;Wheeler, David T.
方法：在一项多中心临床试验中，180名中度弱视(视力为20/40-20/100)的儿童被随机分成两组，分别在周末使用阿托品和单独使用阿托品。主要观察指标：在18周时，使用弱视治疗研究HOTV测试规程对弱视视力进行掩蔽评估。接受阿托品加平镜组的弱视视力改善平均为2.8行，而单独接受阿托品组的弱视视力改善平均为2.4行(经基线视力调整后，两组之间的平均差值为0.3行；95%可信区间，-0.2至0.8行)。在仅接受阿托品治疗的组中，有24名患者(29%)的弱视视力达到或超过20/25，而在接受阿托品加平板镜片的治疗组中，有35名患者(40%)(P=0.03)。在接受阿托品加平坦镜的组中，更多的患者在18周时视力下降；然而，没有持续性反向弱视的病例。结论：作为中度弱视的初始治疗，周末使用阿托品加平镜组与周末单独使用阿托品相比，并不能显著提高弱视视力。临床应用：治疗单侧弱视儿童。试验登记：Clinicaltrials.org
Objective: To compare weekend atropine sulfate use augmented by a plano lens for the sound eye with weekend atropine use alone for moderate amblyopia in children aged 3 years to younger than 7 years.Methods: In a multicenter clinical trial, 180 children with moderate amblyopia (visual acuities of 20/40-20/100) were randomized to weekend atropine use augmented by a plano lens or weekend atropine use alone.Main Outcome Measure: Masked assessment of amblyopic eye visual acuity using the Amblyopia Treatment Study HOTV testing protocol at 18 weeks.Results: At 18 weeks, amblyopic eye improvement averaged 2.8 lines in the group that received atropine plus a plano lens and 2.4 lines in the group that received atropine alone (mean difference between groups adjusted for baseline acuity, 0.3 line; 95% confidence interval, -0.2 to 0.8 line). Amblyopic eye visual acuity was 20/25 or better in 24 patients (29%) in the group that received atropine only and 35 patients (40%) in the group that received atropine plus a plano lens (P = .03). More patients in the group that received atropine plus a plano lens had reduced sound eye visual acuity at 18 weeks; however, there were no cases of persistent reverse amblyopia.Conclusions: As an initial treatment for moderate amblyopia, the augmentation of weekend atropine use with a plano lens does not substantially improve amblyopic eye visual acuity when compared with weekend atropine use alone.Application to Clinical Practice: Treatment of children with unilateral amblyopia.Trial Registration: clinicaltrials.org Identifier: NCT00315302