Eye (London, England) · 2026
Efficacy and safety of 0.01% atropine in Chinese children with nearwork-induced transient myopia: a randomised, double-blind, placebo-controlled trial.
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Fan Yunwei, Peng Yaguang, Zhang Yan, Wang Jiawen, Guo Yanan, Peng Xiaoxia, Bai Xueqing, Hu Man, Wang Yuan, Jiang Jingjing, Liu Wen, Yu Jifeng, Liu Manjun, Ding Qian, Yuan Yue, Liu Xiaomei, Yang Shaopeng, Wang Xiaoling, Li Li
Аннотация
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.
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.