Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.
National Clinical Research Center for Eye Diseases, Shanghai, China.
Trials. 2021 Dec 1;22(1):863. doi: 10.1186/s13063-021-05825-1.
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.
近视在全球范围内的患病率不断上升，目前已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在探索合适的临床干预措施，以减缓儿童近视的进展。越来越多的研究证明，角膜塑形术（OK 镜）和 0.01%阿托品滴眼液均可抑制眼轴增长和近视进展。然而，目前尚不清楚 OK 镜联合 0.01%阿托品是否有可能增强近视控制的效果。本研究旨在比较 OK 镜联合 0.01%阿托品与 OK 镜单药治疗儿童近视的控制效果。
本研究为一项随机、对照、双盲、多中心临床试验。共招募 96 名 8-12 岁的儿童。这些参与者分别接受 OK 镜联合 0.01%阿托品滴眼液或 OK 镜联合安慰剂滴眼液治疗。每组各 48 名参与者。纳入标准为：双眼近视 -1.00 至-4.00D，散光不超过 1.50D。随访时间点为随机分组后 1、6、12、18 和 24 个月。主要结局指标为两组间随机分组后 24 个月时眼轴长度的差异。
本随机对照临床试验将表明 OK 镜联合 0.01%阿托品在延缓儿童近视进展和眼轴增长方面的附加效果及其程度。
中国临床试验注册中心（ChiCTR），ChiCTR1800018419。注册于 2018 年 9 月 17 日。http://www.chictr.org.cn/showproj.aspx?proj=29216。
