Japanese journal of ophthalmology · 2026
Beyond mild myopia: a pilot randomized trial of 0.01% atropine in school-aged children with myopia ≤ -4.50 D.
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Tanaka Eizo, Morizane Yuki, Fujii Seiko, Yaida Mari, Sun Weiying, Hasebe Satoshi
Аннотация
PURPOSE: To conduct an exploratory randomized trial evaluating the efficacy of 0.01% atropine in schoolchildren with myopia ≤ -4.50 D.
STUDY DESIGN: Open-label, randomized crossover pilot trial.
METHODS: In this 24-month trial, 19 children were assigned to atropine/control (n = 9) or control/atropine (n=10) sequences, with crossover at 12 months. During the atropine periods, participants instilled 0.01% atropine nightly. Spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and 6, 12, 18, and 24 months. Twelve-month eye-level changes in periods (0-12 and 12-24 months) were analyzed using linear regression with treatment (atropine vs control) and period as fixed effects and participant-clustered robust standard errors. Mixed-effects models were used to describe trajectories.
RESULTS: Baseline SER ranged from -11.02 to -4.50 D. Mean (±SD) 12-month SER progression was -1.02 ± 0.52 D/year under control and -0.75 ± 0.47 D/year under atropine, yielding an adjusted treatment effect of +0.26 D/year (95% CI, +0.08 to +0.45; p = 0.005; 26% inhibition). Mean AL elongation was +0.40 ± 0.18 mm/year under control and +0.34 ± 0.18 mm/year under atropine, with an adjusted difference of -0.05 mm/year (95% CI, -0.11 to +0.00; p = 0.065; 14% inhibition). Treatment-by-period interactions were not significant for either SER or AL, but rebound could not be excluded given the small sample size.
CONCLUSIONS: In the present cohort, 0.01% atropine suppressed myopia progression over 12 months, with inhibition ratios similar to previous trials involving mild to moderate myopia. These findings support the feasibility of low-dose atropine for advanced myopia and justify full-scale trials.
STUDY DESIGN: Open-label, randomized crossover pilot trial.
METHODS: In this 24-month trial, 19 children were assigned to atropine/control (n = 9) or control/atropine (n=10) sequences, with crossover at 12 months. During the atropine periods, participants instilled 0.01% atropine nightly. Spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and 6, 12, 18, and 24 months. Twelve-month eye-level changes in periods (0-12 and 12-24 months) were analyzed using linear regression with treatment (atropine vs control) and period as fixed effects and participant-clustered robust standard errors. Mixed-effects models were used to describe trajectories.
RESULTS: Baseline SER ranged from -11.02 to -4.50 D. Mean (±SD) 12-month SER progression was -1.02 ± 0.52 D/year under control and -0.75 ± 0.47 D/year under atropine, yielding an adjusted treatment effect of +0.26 D/year (95% CI, +0.08 to +0.45; p = 0.005; 26% inhibition). Mean AL elongation was +0.40 ± 0.18 mm/year under control and +0.34 ± 0.18 mm/year under atropine, with an adjusted difference of -0.05 mm/year (95% CI, -0.11 to +0.00; p = 0.065; 14% inhibition). Treatment-by-period interactions were not significant for either SER or AL, but rebound could not be excluded given the small sample size.
CONCLUSIONS: In the present cohort, 0.01% atropine suppressed myopia progression over 12 months, with inhibition ratios similar to previous trials involving mild to moderate myopia. These findings support the feasibility of low-dose atropine for advanced myopia and justify full-scale trials.