Effectiveness of 0.02% and 0.04% Atropine Therapy for Myopia Control in Czech Children: The MARS Trial.

INTRODUCTION

Low-dose atropine eye drops slow childhood myopia progression, but randomized evidence in European children and for intermediate concentrations remains limited. This study evaluated 0.02% and 0.04% atropine for 12-month myopia control in Czech children.

METHODS

The MARS study was an investigator-initiated, phase IIIb, multicenter, randomized, double-masked, placebo-controlled trial. Children aged 6-11 years with documented accelerated prerandomization axial length (AL) elongation and cycloplegic spherical equivalent refraction (SER) from -0.50 to -4.75 D were randomized 2:1:1 to nightly 0.02% atropine, 0.04% atropine, or placebo. The primary endpoint was the between-group difference in AL change at Month 12 for 0.02% atropine versus placebo. Linear mixed-effects models accounted for inter-eye correlation. Repeated-measures and multiple-imputation sensitivity analyses assessed the effect of missing data.

RESULTS

A total of 191 participants (351 eyes) were included in the primary analysis. Compared with placebo, adjusted mean between-group differences in AL change were -0.144 mm for 0.02% atropine (95% confidence interval [CI] -0.201 to -0.087; P < 0.0001) and -0.157 mm for 0.04% atropine (95% CI -0.222 to -0.092; P < 0.0001). Corresponding differences in SER progression were 0.352 D (95% CI 0.199 to 0.505; P < 0.0001) and 0.389 D (95% CI 0.214 to 0.564; P < 0.0001). No statistically significant difference was detected between 0.02 and 0.04% atropine for AL (0.013 mm; 95% CI -0.043 to 0.069; P = 0.8935) or SER (-0.037 D; 95% CI -0.189 to 0.115; P = 0.8802). Sensitivity analyses yielded consistent AL estimates.

CONCLUSIONS

Nightly 0.02% and 0.04% atropine reduced axial elongation and myopia progression over 12 months compared with placebo. The trial was not designed or powered to establish equivalence between the active doses; within this sample, no statistically significant difference was detected between them.

TRIAL REGISTRATION: European Clinical Trials Database (EudraCT no. 2020-002046-16), Clinical Trials Information System (CTIS), EU Clinical Trial (EU CT) no. 2024-515888-54-00.