Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK)

Abstract

Objectives: To evaluate the efficacy and safety of low concentration atropine eye drops for reducing progression of myopia in children in the UK.

Design: Multicentre, double masked, superiority, placebo controlled, randomised trial.

Setting: National Health Service hospital eye services and academic institutions at five UK centres.

Participants: 289 children aged 6-12 years with myopia between -0.50 and -10.0 dioptres (D). Participants were allocated in ratio of 2:1 to atropine or placebo.

Interventions: One eye drop of preserved atropine 0.01% or placebo daily for two years.

Main outcome measures: The primary outcome was spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia after two years. Secondary outcomes included change in axial length, best corrected distance and near visual acuity, reading speed, pupil diameter, spectacle correction, adverse event rates, quality of life, and tolerability. Outcomes were collected every six months. An electronic monitoring system was used to assess adherence.

Results: 192 participants were included in the atropine group and 97 in the placebo group, with an average age of 9.3 years (standard deviation (SD) 1.7 years). 207 (72%) reported white ethnicity, 161 (56%) were girls, and the mean level of myopia was -2.87 D (SD 1.71 D). A total of 235 (81%) participants completed the study, with primary outcome data available for 230 (80%) participants: 151 (79%) in the atropine group and 79 (81%) in the placebo group. Atropine eye drops were more effective than placebo in reducing myopia progression (mean difference 0.33 D, 95% confidence interval (CI) 0.17 to 0.49 D, P<0.001). Prespecified subgroup analyses did not show differences according to age, ethnicity, sex, or severity of myopia. Changes in central axial length were significantly less in the atropine group versus placebo group: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001). There were no differences in other secondary outcomes, except pupil diameter, which was greater in the atropine group (0.36 mm, 95% CI 0.17, 0.55, P<0.001), and no differences in frequency of adverse events or in tolerability measures. No serious adverse events were related to the trial drugs.

Conclusions: Low concentration atropine (0.01%) eye drops significantly reduced progression of myopia and were well tolerated compared with placebo in children in the UK.

Trial registration: ISRCTN registry ISRCTN99883695, ClinicalTrials.gov NCT03690089.