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Inducement and Evaluation of a Murine Model of Experimental Myopia
Published on: January 22, 2019
Beyond mild myopia: a pilot randomized trial of 0.01% atropine in school-aged children with myopia ≤ -4.50 D
Eizo Tanaka1, Yuki Morizane1, Seiko Fujii2
1Department of Ophthalmology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Insights
Low-dose atropine eye drops effectively slowed myopia progression in schoolchildren over 12 months. This study supports further trials for advanced myopia treatment using low-concentration atropine.
Area of Science:
- Ophthalmology
- Pediatric Ophthalmology
- Clinical Trials
Background:
- Myopia, or nearsightedness, is a growing public health concern, particularly in children.
- Effective interventions for slowing myopia progression are crucial to prevent associated visual impairments.
Purpose of the Study:
- To evaluate the efficacy of 0.01% atropine in reducing myopia progression in schoolchildren.
- To assess the impact of low-dose atropine on spherical equivalent refraction (SER) and axial length (AL) over 24 months.
Main Methods:
- An open-label, randomized crossover pilot trial involving 19 schoolchildren with myopia up to -4.50 D.
- Participants received either 0.01% atropine or a control, with a crossover at 12 months.
- Spherical equivalent refraction and axial length were measured regularly over 24 months.
Main Results:
- Over 12 months, 0.01% atropine showed a 26% inhibition of SER progression (-0.75 D/year vs. -1.02 D/year) compared to control.
- Axial length elongation was reduced by 14% with atropine treatment (-0.05 mm/year difference), though not statistically significant (p=0.065).
- No significant treatment-by-period interactions were observed, but rebound effects could not be ruled out due to the small sample size.
Conclusions:
- 0.01% atropine demonstrated efficacy in suppressing myopia progression in the studied cohort.
- The inhibition rates were comparable to those seen in trials for mild to moderate myopia.
- Findings support the potential of low-dose atropine for managing advanced myopia and warrant larger-scale clinical trials.
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.
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