A systematic review with meta-analysis on the efficacy of 0.01% atropine eyedrops in preventing myopia progression in worldwide children's populations

Introduction: Atropine eyedrops have long been used off-label to prevent myopia progression in children, and many clinical trials have been published on this topic in the past 30 years. Trials initially tested doses ranging from 0.01% to 1%, but more recently, the interest has turned to low doses, mainly 0.01%. Moreover, the first studies were carried out in Asian populations, but the number of trials conducted in other geographical areas has rapidly increased from 2020 onward. This meta-analysis was aimed at summarizing the evidence on the efficacy of 0.01% atropine eyedrops on the reduction of myopia progression, also comparing study findings from different parts of the world. Methods: Data were obtained from PubMed, Scopus and Web of Science databases from 1 January 1 2020 to 31 July 2024. Randomized controlled trials involving children receiving 0.01% atropine eyedrops for at least 1 year were included. Heterogeneity was quantified by Q, H, and I2 statistics, and a meta-analysis was performed using a random effect model. The risk for bias was assessed using the Cochrane Collaboration (Chapter 6) aspects of bias scale. Results and discussion: The primary outcomes were the differences in spherical equivalent refractive errors and axial length at baseline and after 12 months of treatment with 0.01% atropine eyedrops or placebo. Eleven studies involving 2,046 children (1,172 receiving 0.01% atropine eyedrops and 874 receiving placebo) were included. Atropine was significantly more effective than placebo, with an average reduction of 0.16/year (95% CI: 0.11–0.22) and −0.07/year (95% CI: −0.09 to −0.05) in spherical equivalent refractive errors and axial length, respectively. The efficacy of 0.01% atropine eyedrops vs. placebo was maintained in a subpopulation of subjects after 24 months of treatment. We found no difference in atropine efficacy between Southeast Asian populations (1,063 children, 52%) and populations in various other countries (983 children, 48%).