Safety and Efficacy of Atropine 0.05% Versus 0.01% for Prevention of Myopic Progression in Indian Children: A Randomized Clinical Trial.

Aim This study was conducted to evaluate the effectiveness and safety of 0.01% and 0.05% atropine eye drops in managing myopia progression in children compared to a placebo. Methods This randomized, interventional study was conducted from March 2022 to May 2023 at the All India Institute of Medical Sciences, Bibinagar, Telangana. A total of 272 children aged five to 16 years, with myopia ranging from -1.0 D to -6.0 D and an annual progression greater than 0.5 D, were enrolled. Participants were randomly assigned to three groups: Group A (n=88, atropine 0.01%), Group B (n=90, atropine 0.05%), and Group C (n=94, placebo). Comprehensive ophthalmic examinations, including cycloplegic refraction, axial length measurement, and fundus evaluation, were performed at baseline, six weeks, 12 weeks, and at the end of one year. Changes in refractive error, axial length, accommodation, and pupil size were analyzed. Results Both atropine treatments were effective in slowing myopia progression compared to the placebo. Atropine 0.05% significantly reduced refractive progression (0.263 ± 0.03 D) and axial elongation (0.138 ± 0.22 mm) compared to the placebo group (0.759 ± 0.8 D and 0.367 ± 0.33 mm, respectively). The 0.01% atropine group also demonstrated a reduction, although less pronounced (0.319 ± 0.05 D and 0.241 ± 0.22 mm, respectively). Both atropine groups exhibited an increase in the near point of accommodation and pupil size, with the 0.05% group showing more significant changes. Mild adverse effects, including near vision difficulties and photophobia, were reported but did not significantly impact patient compliance. Conclusion Atropine 0.05% is more effective than 0.01% atropine and placebo in slowing myopia progression in children. Although both concentrations led to increased near point of accommodation and pupil size, side effects were mild and well-tolerated.