Research Review

Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children

February 3, 2025

By Dwight Akerman, OD, MBA, FAAO, Dipl AAO, FBCLA, FIACLE

Photo Credit: Dreamstime Photos

The study “Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children: Three-Year Results of the MOSAIC Randomized Clinical Trial,” conducted by Loughman et al., aimed to address the ongoing need for effective treatments to manage myopia in children. The research specifically focused on the efficacy and safety of various regimens of atropine eye drops, a commonly used therapy for controlling myopia progression in children and adolescents.

The foundation of this study was a secondary analysis of the 24-month Myopia Outcome Study of Atropine in Children (MOSAIC) trial, known as the MOSAIC2 trial. This randomized, double-masked clinical trial included participants from the original MOSAIC trial and was focused on children and adolescents diagnosed with myopia. The trial took place at the Centre for Eye Research Ireland, with data collection occurring from November 2023 to February 2024.

The participants were randomly assigned into two primary cohorts. The first group (Group 1) received a nightly placebo for the initial two years, followed by 0.05% atropine eye drops for one year. In contrast, the second group (Group 2) received nightly 0.01% atropine eye drops for two years, followed by a period of rerandomization into one of three groups: placebo nightly, tapering placebo, or tapering 0.01% atropine for one year. The primary outcomes measured included changes in cycloplegic spherical equivalent refraction and axial length during the final year of the study.

The analysis included 199 children, with a mean age of 13.9 years, drawn from an original cohort of 250. Retention rates were quite high, with approximately 79.5% of participants in Group 1 continuing into the third year and about 79.6% of Group 2 maintaining their participation. Ultimately, completion rates at the end of the study were 73.5% for Group 1 and 72.5% for Group 2.

Results indicated that participants who were initially given a placebo and then 0.05% atropine experienced significantly less myopia progression and axial elongation than those who received the 0.01% atropine regimen followed by tapering treatments. Specifically, there was an adjusted difference of -0.13D in spherical equivalent progression and a 0.06 mm difference in axial length elongation for those on the 0.05% atropine regimen compared to the combined groups that followed the lower concentration regimen.

The adverse effects associated with the different treatments were also documented. At month 36, 15% of participants in Group 1 reported blurred near vision, while 8% experienced photophobia. Conversely, in the group receiving 0.01% atropine followed by tapering, only 3% reported blurred vision, and there were no occurrences of photophobia. Notably, both placebo groups reported no adverse effects during this period.

In conclusion, this study presented compelling evidence that, despite a higher incidence of adverse events, the use of 0.05% atropine eye drops during the third year of treatment was associated with a statistically significant reduction in myopia progression and axial elongation compared to lower-concentration atropine regimens in European children and adolescents. The findings support the efficacy of using higher concentrations of atropine to manage myopia in children and suggest that the treatment offers a vital strategy for mitigating the worsening of myopia among young patients. Given its demonstrated outcomes over the trial’s duration, the research advocates for clinicians to consider adopting the 0.05% atropine regimen as an effective intervention in similar populations.

Abstract

Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children

James Loughman, Gareth Lingham, Ernest Kyei Nkansah, Emmanuel Kobia-Acquah, Daniel Ian Flitcroft  

Importance:  Additional data are required regarding atropine treatment regimens for control of myopia progression.

Objective: To investigate the efficacy and safety of different atropine regimens for myopia in children.

Design, Setting, and Participants:  This was a secondary analysis of the 3-year results of the 24-month Myopia Outcome Study of Atropine in Children (MOSAIC) trial, called the MOSAIC2 trial. The MOSAIC trial was an investigator-led, double-masked, randomized clinical trial of different atropine concentrations and regimens. The MOSAIC2 study took place at the Centre for Eye Research Ireland, in Dublin, Ireland, and included children and adolescents with myopia from the MOSAIC trial. Data analysis was conducted from November 2023 to February 2024.

Interventions: Participants were randomly assigned to the following cohorts: group 1, nightly placebo for 2 years, then 0.05% atropine eye drops for 1 year; and group 2, nightly 0.01% atropine eye drops for 2 years, then rerandomization to placebo nightly, tapering placebo, or tapering of 0.01% atropine eye drops for 1 year.

Main Outcomes and Measures: Observed changes in cycloplegic spherical equivalent refraction and axial length from month 24, or baseline, to month 36.

Results: A total of 199 children with myopia (mean [SD] age, 13.9 [2.4] years; 121 female [60.8%]) of the 250 children and adolescents from the MOSAIC trial were included in the MOSAIC2 trial analysis. Of 83 participants assigned to group 1, 66 (79.5%) reconsented to year 3, and 61 (73.5%) completed the trial. Of 167 participants assigned to group 2, 133 (79.6%) continued to year 3, and 121 (72.5%) completed the trial (0.01% atropine, then nightly placebo: n = 31 and n = 29 [93.5%]; 0.01% atropine, then tapering placebo: n = 29 and n = 25 [86.2%]; 0.01% atropine then tapering 0.01% atropine: n = 73 and n = 67 [91.8%], respectively). Compared with the group taking placebo then 0.05% atropine, the combined atropine then placebo groups had more spherical equivalent progression (adjusted difference, −0.13 diopters [D]; 95% CI, −0.22 to −0.04 D; P = .01) and axial elongation (adjusted difference, 0.06 mm; 95% CI, 0.02-0.09 mm; P = .008), and the group taking 0.01% atropine then tapering 0.01% atropine had more axial elongation (adjusted difference, 0.04 mm; 95% CI, 0.009-0.07 mm; P = .04). In the group taking placebo then 0.05% atropine, 15% (n = 10) and 8% (n = 5) reported blurred near vision and photophobia, respectively, during year 3, compared with 3% (n = 2) and 0%, respectively, in the group taking 0.01% atropine then tapering 0.01% atropine, and no reports in both placebo groups.

Conclusions and Relevance: Despite more adverse events, participants using 0.05% atropine during year 3 had no differences in treatment completion rates and exhibited 0.13-D less myopia progression and 0.06-mm less axial elongation, compared with participants using placebo, supporting consideration of treatment as given to the group taking 0.05% atropine in this European population.

Loughman, J., Lingham, G., Nkansah, E. K., Kobia-Acquah, E., & Flitcroft, D. I. (2024). Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children: Three-Year Results of the MOSAIC Randomized Clinical Trial. JAMA ophthalmology. Published online January 09, 2025.

DOI: 10.1001/jamaophthalmol.2024.5703

 

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