Efficacy and Safety of 0.03% Atropine Eye Drops in Controlling Myopia Progression: A One-Year Prospective Clinical Study.

ABSTRACT

Objective: To investigate the efficacy and safety of one-year treatment with 0.03% atropine eye drops for slowing myopia progression among children aged 6-12 years. Methods: Healthy Caucasian children aged 6-12 years with cycloplegic spherical equivalent (SE) from -1.0 D to -5.0 D and astigmatism and anisometropia ≤1.5 D were included. Changes in mean axial length (AL) and objective SE as well as changes in intraocular pressure (IOP), central corneal thickness (CCT), anterior chamber depth (ACD) and lens thickness (LT) were assessed in the 0.03% atropine eye drops group and the control group from baseline through the 1-year follow-up. The proportion of participants showing myopia progression of <0.5 D from baseline in each group and any potential side effects in 0.03% atropine group were evaluated. Results: The study involved 31 patients in the 0.03% atropine eye drops group and 41 in the control group. Administration of 0.03% atropine for 1 year resulted in a mean change in SE of -0.34 (0.44) D/year, significantly lower than the -0.60 (0.50) D/year observed in the control group (p = 0.024). The change in AL was 0.19 (0.17) mm in the 0.03% atropine group, compared to 0.31 (0.20) mm in the control group (p = 0.015). There were no significant differences in changes of IOP, CCT and LT between the groups (all p ≥ 0.05). The 0.03% atropine group had a significantly greater increase in ACD compared to the control group (p = 0.015). In total, 64.5% of patients in the 0.03% atropine group showed progression <0.5 D/year, in contrast to 39.0% in the control group (p = 0.032). Adverse events were reported in 13 (35.0%) out of 37 patients in the treatment group, leading to discontinuation of the eye drops in six (16.0%) cases. None of the adverse events were severe. Conclusions: Despite a higher incidence of adverse events, 0.03% atropine eye drops effectively slowed the progression of myopia over 1-year.