Different concentrations of atropine in children with high myopia: a 2-year multicenter double-blind, randomized controlled trial
Abstract
High myopia in children risks irreversible visual impairment, yet optimal interventions remain debated. This multicenter double-blind, randomized-controlled trial aims to evaluate the effect and safety of different atropine eyedrops for myopia control in children with high myopia, conducted in Shanghai Eye Diseases Prevention and Treatment Center, Shanghai General Hospital and Shanghai Ninth People's Hospital. Recruitment started on July 4th, 2021 and final follow-up was August, 21st, 2024. 219 children aged 6-12 years with myopia of at least -5.0 diopter (D) were recruited and randomly assigned to use either 0.01%(N = 76), 0.04%(N = 72), or 0.10%(N = 71) atropine eyedrops once nightly for both eyes over 24 months, and 182 participants completed trial; 219 (76:72:71) randomized cases were analyzed. Main outcome was cycloplegic spherical equivalent (SE) change from baseline over 24 months. After 24 months, mean SE progression was -0.92 D, -0.78 D and -0.56 D for 0.01%, 0.04% and 0.10% atropine, respectively. The 0.10% atropine significantly reduced myopia progression by 0.35 D (95%CI: 0.12 D, 0.58 D) versus 0.01%, while 0.04% atropine did not show significant difference; however, at 12 months, both higher concentrations demonstrated significantly greater reductions (0.16 D and 0.30 D for 0.04% and 0.10%, respectively). Photophobia was the most common adverse event, reported by 9.0%, 10.6% and 18.8% in 0.01%, 0.04% and 0.10% atropine respectively in 12 months and 7.8%, 8.1% and 21.1% in 24 months. These results demonstrated that in children aged 6-12 years with high myopia, nightly use of 0.10% atropine for 24 months effectively and safely attenuated myopia progression. Trial Registration: ClinicalTrials.gov, NCT04699357.
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BibTeX
@article{du2026different,
title = {{Different concentrations of atropine in children with high myopia: a 2-year multicenter double-blind, randomized controlled trial}},
author = {Linlin Du and Zhehui Liu and Tianyu Cheng and Weili Yan and Bilian Ke and Ying Yuan and Xinxin Li and Jibo Zhou and Jun Chen and Jingjing Wang and Chi Pui Pang and Haidong Zou and Wei Gao and Xun Xu and Xiangui He},
journal = {Nature Communications},
year = {2026},
month = oct,
doi = {10.1038/s41467-026-77797-2},
url = {https://www.nature.com/articles/s41467-026-77797-2},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Different concentrations of atropine in children with high myopia: a 2-year multicenter double-blind, randomized controlled trial
AU - Linlin Du
AU - Zhehui Liu
AU - Tianyu Cheng
AU - Weili Yan
AU - Bilian Ke
AU - Ying Yuan
AU - Xinxin Li
AU - Jibo Zhou
AU - Jun Chen
AU - Jingjing Wang
AU - Chi Pui Pang
AU - Haidong Zou
AU - Wei Gao
AU - Xun Xu
AU - Xiangui He
PY - 2026
DA - 2026/10/02
JO - Nature Communications
DO - 10.1038/s41467-026-77797-2
UR - https://www.nature.com/articles/s41467-026-77797-2
AB - High myopia in children risks irreversible visual impairment, yet optimal interventions remain debated. This multicenter double-blind, randomized-controlled trial aims to evaluate the effect and safety of different atropine eyedrops for myopia control in children with high myopia, conducted in Shanghai Eye Diseases Prevention and Treatment Center, Shanghai General Hospital and Shanghai Ninth People's Hospital. Recruitment started on July 4th, 2021 and final follow-up was August, 21st, 2024. 219 children aged 6-12 years with myopia of at least -5.0 diopter (D) were recruited and randomly assigned to use either 0.01%(N = 76), 0.04%(N = 72), or 0.10%(N = 71) atropine eyedrops once nightly for both eyes over 24 months, and 182 participants completed trial; 219 (76:72:71) randomized cases were analyzed. Main outcome was cycloplegic spherical equivalent (SE) change from baseline over 24 months. After 24 months, mean SE progression was -0.92 D, -0.78 D and -0.56 D for 0.01%, 0.04% and 0.10% atropine, respectively. The 0.10% atropine significantly reduced myopia progression by 0.35 D (95%CI: 0.12 D, 0.58 D) versus 0.01%, while 0.04% atropine did not show significant difference; however, at 12 months, both higher concentrations demonstrated significantly greater reductions (0.16 D and 0.30 D for 0.04% and 0.10%, respectively). Photophobia was the most common adverse event, reported by 9.0%, 10.6% and 18.8% in 0.01%, 0.04% and 0.10% atropine respectively in 12 months and 7.8%, 8.1% and 21.1% in 24 months. These results demonstrated that in children aged 6-12 years with high myopia, nightly use of 0.10% atropine for 24 months effectively and safely attenuated myopia progression. Trial Registration: ClinicalTrials.gov, NCT04699357.
SN - 2041-1723
ER -