Ophthalmology and therapy · 2026
Effectiveness of 0.02% and 0.04% Atropine Therapy for Myopia Control in Czech Children: The MARS Trial.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hložánek Martin, Dostálek Miroslav, Autrata Rudolf, Štěpánová Radka, Vinklerová Jana Unar, Heissigerová Jarmila, Studený Pavel, Čáslavská Barbora, Jeřábková Lucie, Zelenayová Nina, Krejčířová Inka, Brunnerová Renáta, Korbasová Marta, Komínek Martin
Аннотация
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.
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.