Efficacy of combined orthokeratology and 0.01% atropine for myopia control: the study protocol for a randomized, controlled, double-blind, and multicenter trial

Trials

Bilian Ke¹  Ying Yuan¹  Mingming Liu²  Yali Zhou²  Chengcheng Zhu³  Xinjie Mao⁴  Bingru Zheng⁵  Zhouyue Li⁵  Xiao Yang⁵ 

[1] Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 200080, Shanghai, China;National Clinical Research Center for Eye Diseases, Shanghai, China;Shanghai Key Laboratory of Fundus Disease, Shanghai, China;Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 200080, Shanghai, China;Shanghai Key Laboratory of Fundus Disease, Shanghai, China;Shanghai Engineering Center for Precise Diagnosis and Treatment of Eye Diseases, Shanghai, China;Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 200080, Shanghai, China;Shanghai Key Laboratory of Fundus Disease, Shanghai, China;Shanghai Engineering Center for Visual Science and Photomedicine, Shanghai, China;School of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, 325027, Wenzhou, Zhejiang, China;State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center Sun Yat-Sen University, Guangzhou, China;

关键词: Myopia control;    Orthokeratology;    0.01% atropine;    Pediatrics, Multicenter trial;   

DOI  :  10.1186/s13063-021-05825-1

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsThe 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.DiscussionThe 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.Trial registrationChinese Clinical Trial Registry (ChiCTR), ChiCTR1800018419. Registered on 17 September 2018. http://www.chictr.org.cn/showproj.aspx?proj=29216

【 授权许可】

CC BY