Effectiveness of 0.02% and 0.04% Atropine Therapy for Myopia Control in Czech Children: The MARS Trial.
8 affiliations
- 1Department of Ophthalmology for Children and Adults, Second Faculty of Medicine, Charles University and University Hospital Motol and Homolka, V Úvalu 84, 15006, Prague 5, Czech Republic. [email protected].
- 2Center of Pediatric Ophthalmology, BINOCULAR S.R.O., Litomyšl, Czech Republic.
- 3Department of Optometry and Orthoptics, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
- 4Department of Pediatric Ophthalmology, Faculty of Medicine, Masaryk University and University Hospital Brno, Brno, Czech Republic.
- 5Center of Excellence CREATIC, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
- 6Department of Ophthalmology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.
- 7Department of Ophthalmology, Third Faculty of Medicine, Charles University and University Hospital Královské Vinohrady, Prague, Czech Republic.
- 8Department of Ophthalmology for Children and Adults, Second Faculty of Medicine, Charles University and University Hospital Motol and Homolka, V Úvalu 84, 15006, Prague 5, Czech Republic.
Abstract
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.
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BibTeX
@article{hlozanek2026effectiveness,
title = {{Effectiveness of 0.02% and 0.04% Atropine Therapy for Myopia Control in Czech Children: The MARS Trial.}},
author = {Martin Hložánek and Miroslav Dostálek and Rudolf Autrata and Radka Štěpánová and Jana Unar Vinklerová and Jarmila Heissigerová and Pavel Studený and Barbora Čáslavská and Lucie Jeřábková and Nina Zelenayová and Inka Krejčířová and Renáta Brunnerová and Marta Korbasová and Martin Komínek},
journal = {Ophthalmology and therapy},
year = {2026},
month = oct,
doi = {10.1007/s40123-026-01506-x},
url = {https://europepmc.org/article/MED/42832165},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Effectiveness of 0.02% and 0.04% Atropine Therapy for Myopia Control in Czech Children: The MARS Trial.
AU - Martin Hložánek
AU - Miroslav Dostálek
AU - Rudolf Autrata
AU - Radka Štěpánová
AU - Jana Unar Vinklerová
AU - Jarmila Heissigerová
AU - Pavel Studený
AU - Barbora Čáslavská
AU - Lucie Jeřábková
AU - Nina Zelenayová
AU - Inka Krejčířová
AU - Renáta Brunnerová
AU - Marta Korbasová
AU - Martin Komínek
PY - 2026
DA - 2026/10/05
JO - Ophthalmology and therapy
DO - 10.1007/s40123-026-01506-x
UR - https://europepmc.org/article/MED/42832165
AB - 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.
SN - 2193-8245
SN - 2193-6528
ER -