Abstract / Summary
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. Here the authors report the results of a multicenter, double-blind, randomized-controlled trial that evaluates the effect and safety of different concentration atropine eyedrops (0.01%, 0.04%, 0.10%) for myopia control in children with high myopia. The findings show that nightly use of 0.10% atropine eye drops for 24 months mitigated myopia progression with an acceptable safety profile.