Low concentration atropine eye drops are a safe and effective treatment for short-sightedness (myopia) in UK children, although the effects are small, suggests a clinical trial published by The BMJ today.
The researchers say the drops led to small but significant reductions in myopia progression compared with placebo, and are "a worthwhile addition to currently available optical interventions for the treatment of myopia in children in the UK."
Rates of myopia in children are increasing worldwide, and are linked to higher healthcare costs and long term eye-related complications
Atropine eye drops are used worldwide to treat myopia in children, but are not currently available in the NHS, so their effectiveness and safety in children in the UK is uncertain.
To address this knowledge gap, researchers recruited 289 children with myopia aged 6-12 years (average age 9.3 years; 72% reported white ethnicity; 56% were girls) from five NHS hospital eye services and academic institutions between June 2019 and February 2022. All children wore standard spectacles to correct myopia.
A total of 192 children received daily 0.01% atropine eye drops and 97 received placebo for two years, in addition to standard spectacles. Myopia progression, eye growth, safety, and tolerability were monitored every six months.
Final results were available for 230 children (151 in the atropine group and 79 in the placebo group).
After accounting for factors such as age, ethnicity, and history of myopia in at least one parent, children who used atropine eye drops experienced a small decrease in myopia progression and eye growth compared with those using placebo drops.
Specifically, atropine treatment led to an average reduction of 0.38 D (diopter) in refractive error and 0.14 mm in central axial length - two key measures of myopia - compared with placebo.
Pupil diameter was the only other outcome with a notable difference (0.36 mm greater in the atropine group). No differences were seen in the frequency of adverse events or in tolerability measures, such as sore eyes, blurry vision, itchiness, or difficulty reading and writing.
The researchers acknowledge several trial limitations, such as the generalisability of results outside of a clinical trial environment and the potential influence of the covid-19 pandemic, which occurred during the trial period.
Nevertheless, they conclude: "The findings suggest that a low concentration atropine eye drop product would be a worthwhile addition to currently available optical interventions for the treatment of myopia in children in the UK."
These results will help inform policymakers in the UK, they add.