0.01% Atropine for Myopia Prevention in Pre‐myopia ( AMPP study)

Abstract Purpose This study aimed to evaluate the efficacy and safety of 0.01% atropine eye drops in preventing myopia in children with pre‐myopia. Methods In this randomised controlled trial (ChiCTR2200055482), children aged 5–12 years with cycloplegic spherical equivalent (SE) between +0.75D and −0.50D were randomised 1:1 to receive either 0.01% atropine (once nightly) or placebo (once nightly). The primary endpoint was the change in SE after 12 months. Results Sixty‐four subjects (48.4% female) completed the 12‐month follow‐up (32 per group, mean age, 7.47 ± 1.72 vs. 7.84 ± 1.32 years). After 12 months, the change in SE was significantly smaller in the 0.01% atropine group than in the placebo group (−0.23 ± 0.50D vs. −0.49 ± 0.42D; p = 0.03), representing a 53% reduction in myopia progression. No significant intergroup difference was observed in axial length (AL) change (+0.26 ± 0.16 mm vs. +0.32 ± 0.15 mm; p = 0.13), corresponding to a 19% reduction in AL elongation. The 0.01% atropine group exhibited significantly larger pupil diameters at all time points (all p < 0.05), while safety parameters (e.g., amplitude of accommodation, tear film stability, intraocular pressure) remained comparable between the groups (all p > 0.05). Conclusion In 5‐ to 12‐year‐old pre‐myopic children, nightly administration of 0.01% atropine eye drops for 1 year was found to delay myopic shift compared with placebo, and no persistent adverse events were observed. Additionally, the atropine group exhibited less axial elongation than the control group, though this difference was not statistically significant.