Aims: To evaluate the efficacy and safety of 0.01% atropine eye-drops in controlling myopia progression over 5 years.
Methods: Experimental, analytical, prospective, randomised and longitudinal study, in 361 right eyes from 361 children randomised into the control group (177 eyes without treatment) and treatment group (184 eyes with 0.01% atropine eye-drops). Children assigned to the treatment group used 0.01% atropine once a day every night and the control group's children did not use any treatment or placebo. All the subjects completed an eye examination every 6 months for the 5 years of follow-up. The examination included subjective and objective refraction with cycloplegia, axial length (AL), keratometry and anterior chamber depth (ACD) to evaluate the efficacy of the treatment. It also included the anterior and posterior pole examination to evaluate the safety of the treatment.
Results: The SE increased -0.63±0.42D in children after 5 years of treatment with 0.01% atropine, while in the control group the increase was -0.92±0.56D. AL increased 0.26±0.28 mm in the treatment group compared with 0.49±0.34 mm in the control group. Atropine 0.01% showed an efficacy of 31.5% and 46.9% in the control of the SE and AL increase, respectively. ACD and keratometry did not have significant changes between groups.
Conclusions: Atropine 0.01% is effective in slowing myopia progression in a European population. There were no side effects after 5 years of 0.01% atropine.
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