Peer-reviewed article
Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children
James Loughman, Gareth Lingham, Ernest Kyei Nkansah, Emmanuel Kobia‐Acquah, Ian Flitcroft ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study compared different regimens of atropine eye drops for treating myopia progression in Irish children over three years. Children receiving 0.05% atropine in the third year showed less myopia progression and less eye elongation than those receiving placebo, though some experienced blurred near vision and light sensitivity. The results suggest that 0.05% atropine treatment may be effective for slowing myopia progression in European children, despite these side effects.
Key points
- 199 children with myopia (mean age 13.9 years) from Ireland completed analysis of three-year treatment regimens
- Group receiving placebo then 0.05% atropine showed 0.13 diopters less myopia progression and 0.06mm less axial elongation compared to those receiving atropine then placebo
- 15% of children receiving 0.05% atropine reported blurred near vision and 8% reported photophobia during year 3
- Completion rates were similar across all treatment groups despite adverse events
- Stopping atropine or switching to placebo resulted in increased myopia progression compared to continued treatment
Limitations
This is a secondary analysis of a single trial conducted in Ireland, so findings may not generalize to other populations or regions. The study does not provide long-term follow-up beyond three years to assess sustained effects or late-onset adverse events.
Abstract
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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Different atropine eye drop regimens: 0.05% atropine nightly for one year; 0.01% atropine nightly for two years followed by placebo, tapering placebo, or tapering atropine for one year
- Population
- 199 children and adolescents with myopia in Ireland, mean age 13.9 years (60.8% female)
Key finding
0.05% atropine in year 3 produced 0.13 diopters less spherical equivalent progression than placebo (P = 0.01)