A Pilot Study on the Efficacy and Safety of 0.01% Atropine in German Schoolchildren with Progressive Myopia.

Introduction: Although the interest is growing in topical low-dose atropine to control myopia in schoolchildren worldwide, its use in children of European ancestry remains controversial and solid evidence is sparse. The Oxford Centre for Evidence Based Medicine (OCEBM) classifies the evidence for this therapy as level I for East Asian populations, but only level IV in non-Asian populations.

Methods: Fifty-six children, aged a median of 11 years (range 6-17), were analysed after 12 months of topical treatment with 0.01% preservative-free atropine in both eyes at bedtime every day. Efficacy was assessed during treatment every 6 months. In a subset of 20 patients, treatment of the second eye was delayed by 1 day to enable a controlled safety assessment of side effects such as pupil dilation, hypoaccommodation, and near vision reduction.

Results: Prior to treatment, the mean myopic progression was estimated as 1.05 D/year; after 12 months of treatment with 0.01% atropine, it was 0.40 D/year (p < 0.0001). The only consistently measurable side effect was the induction of 1 mm pupil dilatation, which was only noticeable in comparison to the non-treated eye during the safety investigation.

Conclusions: Topical low-dose atropine appears to be safe and efficacious also in a cohort of European schoolchildren. These data should motivate researchers to conduct more randomised clinical trials.