A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

Shanghai Eye Disease Prevention and Treatment Center0 个研究点目标入组 588 人2023年1月15日

适应症Myopia, Progressive

干预措施low concentration atropine (0.01%)low concentration atropine (0.025%)low concentration atropine (0.05%)Placebo

概览

阶段: 不适用
干预措施: low concentration atropine (0.01%)
疾病 / 适应症: Myopia, Progressive
发起方: Shanghai Eye Disease Prevention and Treatment Center
入组人数: 588
主要终点: Proportion of SE changes over -0.75D
状态: 尚未招募
最后更新: 3年前

概览研究者入排标准研究组 & 干预措施结局指标相似试验

概览

简要总结

To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

注册库

clinicaltrials.gov

开始日期

2023年1月15日

结束日期

2025年11月1日

最后更新

3年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Shanghai Eye Disease Prevention and Treatment Center

责任方

Sponsor

入排标准

入选标准

•The age of the screening stage is 3-15 years, both sexes;
•One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
•Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
•Informed consent from the guardian and the child.