Efficacy of combined orthokeratology and 0.01% atropine for myopia control: the study protocol for a randomized, controlled, double-blind, and multicenter trial.
Efficacy of combined orthokeratology and 0.01% atropine for myopia control: the study protocol for a randomized, controlled, double-blind, and multicenter trial.
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%20%20联合%20角膜塑形术%20和%200.01%%20阿托品%20用于%20近视%20对照的疗效：%20%20研究%20方案%20用于%20a%20随机、%20对照、%20双盲%20和%20多中心%20试验
DOI：
10.1186/s13063-021-05825-1
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发表时间：
2021-12-01
期刊：
影响因子：
2.5
通讯作者：
Ke B
中科院分区：
文献类型：
--
作者：
Yuan Y;Zhu C;Liu M;Zhou Y;Yang X;Zheng B;Li Z;Mao X;Ke B
近视的患病率在世界范围内不断增加，目前被认为是一个主要的公共卫生问题。研究人员和临床医生一直致力于探索适当的临床干预措施，以减缓其在儿童中的进展。越来越多的出版物已经证明，角膜塑形术（OK透镜）和0.01%阿托品眼药水都可以延缓眼睛生长和近视进展。然而，目前尚不清楚OK透镜和0.01%阿托品的组合是否有可能放大近视控制的有效性。本研究旨在比较OK透镜联合0.01%阿托品与单用OK透镜治疗儿童近视的疗效。本研究是一项随机、对照、双盲、多中心的临床试验。共招募了96名8-12岁的儿童。这些受试者接受OK透镜和0.01%阿托品眼药水联合治疗或OK透镜和安慰剂眼药水联合治疗。每组包括48名参与者。入选标准如下：任何一只眼睛的近视在-1.00和-4.00 D之间，散光不超过1.50 D。随访时间点为随机化后1、6、12、18和24个月。主要结局由两组基线和随机化后24个月的眼轴长度差异确定。目前的随机对照临床试验将表明OK透镜和0.01%阿托品组合在延缓儿童近视进展和眼轴延长方面的累加效应以及这些效应的程度。中国临床试验注册中心（ChiCTR），ChiCTR 1800018419。于2018年9月17日注册。http://www.chictr.org.cn/showproj.aspx? proj=29216在线版本包含补充材料，可通过10.1186/s13063-021-05825-1获得。
The prevalence of myopia is increasing worldwide and is presently recognized as a major public health issue. Researchers and clinicians have been devoted in exploring appropriate clinical interventions to slow its progression in children. Mounting publications have proven that both orthokeratology (OK lens) and 0.01% atropine eyedrop can retard eye growth and myopia progression. However, it remains unclear whether the combination of OK lens and 0.01% atropine has the potential to magnify the effectiveness of myopia control. The present study aims to compare the myopia control efficiency of the combination of OK lens and 0.01% atropine with the monotherapy of OK lens in children. The present study is a randomized, controlled, double-blind and multicenter clinical trial. A total of 96 children within 8–12 years old were recruited. These participants are treated with the combination of OK lens and 0.01% atropine eyedrop or the combination of OK lens and placebo eyedrop. Each group includes 48 participants. The inclusion criteria are as follows: myopia between − 1.00 and − 4.00 D in either eye and astigmatism of no more than 1.50 D. The follow-up time points will be 1, 6, 12, 18, and 24 months from randomization. The primary outcome is determined by the difference in axial length of the two groups, between the baseline and 24 months from randomization. The present randomized, controlled clinical trial would indicate the additive effects of the combination of OK lens and 0.01% atropine, and the extent of these effects, in retarding myopia progression and axial elongation in children. Chinese Clinical Trial Registry (ChiCTR), ChiCTR1800018419. Registered on 17 September 2018. http://www.chictr.org.cn/showproj.aspx?proj=29216 The online version contains supplementary material available at 10.1186/s13063-021-05825-1.
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