drugset / Trial / NCT03949101
Atropine for Children and Adolescent Myopia Progression Study
Phase 4
Unknown
222 enrolled
Shanghai Eye Disease Prevention and Treatment Center
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Investigators are going to conduct a randomized controlled trial that myopic children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group) in order to explore a better way to control myopia progression and eliminate adverse effects at the same time, provide reliably evidence for clinical guideline of atropine use in children, and investigate the mechanism of atropine on eyes.
Timeline
- Start
- 2019-05-08
- Primary completion
- 2021-05-08
- Completion
- 2021-09-01
Publications
- Zhao LQ, Ye LY, Chen J, Zhu XF, Xu HN, Yu T, Peng YJ, He JN, Zhu JF. Comparison of the influence of 1% and 0.01% atropine on the corneal topography in myopic children. BMC Ophthalmol. 2025 Nov 18;25(1):650. doi: 10.1186/s12886-025-04465-2.
- Xu H, Ye L, Peng Y, Yu T, Li S, Weng S, Huang Y, Chen Y, Fan Y, Zou H, He J, Zhu J, Xu X. Potential Choroidal Mechanisms Underlying Atropine's Antimyopic and Rebound Effects: A Mediation Analysis in a Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2023 Apr 3;64(4):13. doi: 10.1167/iovs.64.4.13.
- Ye L, Xu H, Shi Y, Yin Y, Yu T, Peng Y, Li S, He J, Zhu J, Xu X. Efficacy and Safety of Consecutive Use of 1% and 0.01% Atropine for Myopia Control in Chinese Children: The Atropine for Children and Adolescent Myopia Progression Study. Ophthalmol Ther. 2022 Dec;11(6):2197-2210. doi: 10.1007/s40123-022-00572-1. Epub 2022 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atropine | Other / unclassified | 0.01 % | Topical |