Efficacy and Safety of Atropine 0.01% for Pediatric Control: A Meta-analysis

Abstract

Introduction: Low-dose atropine (0.01%) has a promising pharmacological effect for slowing pediatric myopia progression. Yet, its specific efficacy and safety profile require ongoing evaluation. Methods: Following PRISMA guidelines and a PROSPERO registered protocol, this systematic review and meta-analysis analyzed randomized controlled trials from the last five years using the Cochrane RoB 2 tool. Primary outcomes are spherical equivalent refraction (SE) and axial length (AL) changes, were synthesized via a random-effects model with subgroup analyses by ethnicity. Result: Five RCTs (n=800) were included. Atropine 0.01% significantly reduced myopia progression over controls. The pooled mean difference (MD) for SE change was 0.24 D (95% CI: 0.18–0.31; p < 0.00001; I²=0%) showing consistent effects in Asian (MD: 0.24 D) and European children (MD: 0.25 D). For AL, atropine significantly limited axial elongation (MD: −0.11 mm; 95% CI: −0.16 to −0.05; p= 0.0003; I² = 64%). Adverse events showed no statistically significant difference between groups (OR: 0.89; 95% CI: 0.56–1.42). Conclusion: Atropine 0.01% is an effective, safe pediatric myopia control treatment, demonstrating consistent refractive and structural benefits across ethnic groups without increasing adverse events.