Efficacy and safety of 0.01% atropine in Chinese children with nearwork-induced transient myopia: a randomised, double-blind, placebo-controlled trial.

BACKGROUND

Nearwork-induced transient myopia (NITM) is a temporary reduction in distance vision following prolonged nearwork and is associated with an increased risk of myopia progression. This study aimed to evaluate the efficacy and safety of 0.01% atropine in controlling NITM in Chinese children.

METHODS

This randomised, double-blind, placebo-controlled trial enrolled Chinese children aged 6-15 years with myopia. Participants were randomised 1:1 to receive 0.01% atropine or placebo eye drops once nightly for 12 weeks, followed by a 12-week observation period. The primary endpoint was the change in initial NITM values from baseline to week 12.

RESULTS

A total of 148 participants were randomised to the 0.01% atropine group (n = 74) or placebo group (n = 74). The mean change in initial NITM from baseline to week 12 was 0.61 ± 0.31 dioptres (D) in the 0.01% atropine group versus 0.18 ± 0.56 D in the placebo group (P < 0.001). Significant differences were also observed in initial NITM at week 2 (-0.28 ± 0.16 D vs. -0.47 ± 0.42 D, P = 0.001) and week 12 (-0.08 ± 0.09 D vs. -0.52 ± 0.30 D, P < 0.001). The repeated measures analysis of variance demonstrated significantly improvements in initial NITM values in the 0.01% atropine group at week 2 (P = 0.047) and week 12 (P < 0.001) compared to placebo. Adverse events (AEs) were reported in 27 participants (37.0%) in the 0.01% atropine group and 30 participants (41.7%) in the placebo group. No serious AEs were reported.

CONCLUSION

Atropine (0.01%) significantly reduces initial NITM values in myopic children, demonstrating sustained benefits up to 12 weeks post-treatment and a favourable safety profile.