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.
- Child health (paediatrics)
Data availability statement
Data are available on reasonable request. No data are available.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Contributors MM-C, MAS-T, CA-P and RR-A researched literature and conceived the study. MM-C was involved in protocol development, gaining ethical approval. MM-C, FJM-M and AG-B were involved in the patient recruitment and examinations. CM-P, MAS-T and CA-P were involved in the data analysis. CM-P and CA-P wrote the first draft of the manuscript. MM-C is responsible for the overall content as guarantor. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.