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Purpose <p>To conduct an exploratory randomized trial evaluating the efficacy of 0.01% atropine in schoolchildren with myopia ≤ −4.50 D.</p> Study design <p>Open-label, randomized crossover pilot trial.</p> Methods <p>In this 24-month trial, 19 children were assigned to atropine/control (<i>n</i>&#xa0;=&#xa0;9) or control/atropine (<i>n</i>=10) sequences, with crossover at 12&#xa0;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&#xa0;months. Twelve-month eye-level changes in periods (0–12 and 12–24&#xa0;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.</p> Results <p>Baseline SER ranged from −11.02 to −4.50 D. Mean (±SD) 12-month SER progression was −1.02&#xa0;±&#xa0;0.52 D/year under control and −0.75&#xa0;±&#xa0;0.47 D/year under atropine, yielding an adjusted treatment effect of +0.26 D/year (95% CI, +0.08 to +0.45; p&#xa0;=&#xa0;0.005; 26% inhibition). Mean AL elongation was +0.40&#xa0;±&#xa0;0.18&#xa0;mm/year under control and +0.34&#xa0;±&#xa0;0.18 mm/year under atropine, with an adjusted difference of −0.05&#xa0;mm/year (95% CI, −0.11 to +0.00; p&#xa0;=&#xa0;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.</p> Conclusions <p>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.</p>

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Beyond mild myopia: a pilot randomized trial of 0.01% atropine in school-aged children with myopia ≤ −4.50 D

  • 期刊论文

  • 发表日期：

    2026年7月21日

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  • Eizo Tanaka,
  • Yuki Morizane,
  • Seiko Fujii,
  • Mari Yaida,
  • Weiying Sun,
  • Satoshi Hasebe

摘要

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.