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

Pierluigi Navarra^1*Luca Buzzonetti²Valentina Amico³Melina Cro³Bruno Federico⁴

• ¹Catholic University of the Sacred Heart, Milano, Italy
• ²Bambino Gesù Children's Hospital (IRCCS), Rome, Lazio, Italy
• ³Medivis Srl, Catania, Italy
• ⁴University of Cassino, Cassino, Lazio, Italy

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 were initially testing doses ranging from 0.01 to 1%, but recently the interest was focused on low doses, mainly 0.01%. Moreover, first studies were carried out in Asian populations, but the number of trials conducted in other geographical areas has rapidly increased from 2020 on. 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. Data were obtained from PubMed Scopus and Web of Science databases, from January 1st, 2020, to July 31, 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 6 aspects of bias scale. The primary outcomes were the differences in spherical equivalent refractive errors and axial length between 0.01% Atropine eyedrops and placebo, at baseline and after 12 months of treatment. Eleven studies involving 2046 children (1172 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 South-east Asian populations (1063 children, 52%) and various other countries (983 children, 48%).