Key PointsQuestion
What is the efficacy and safety of different atropine eye drop regimens, 0.05% and 0.01%, in treating myopia progression in European eyes?
Findings
In this secondary analysis of the 3-year results of the 24-Month Myopia Outcome Study of Atropine in Children (MOSAIC) randomized clinical trial including 199 children and adolescents, among 66 participants switched from placebo to nightly 0.05% atropine eye drops in year 3, approximately 20% experienced transient blurred near vision or photophobia but no treatment discontinuation. The group receiving nightly 0.05% atropine eye drops exhibited less 12-month axial eye growth than participants switched from nightly 0.01% atropine eye drops to either placebo or tapering of 0.01% atropine eye drops.
Meaning
These findings support consideration of treatment of childhood myopia with 0.05% atropine eye drops despite more adverse events in this group.
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.
Trial Registration
isrctn.org Identifier: ISRCTN36732601
