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January 12, 2025 — Dublin, Ireland
A secondary analysis of the 24-Month Myopia Outcome Study of Atropine in Children (MOSAIC) trial has revealed that low-dose atropine eye drops (0.05%) effectively curb myopia progression and axial elongation in children. However, despite the positive results, some participants experienced side effects such as blurred vision and photophobia.
The analysis, led by James Loughman, PhD, from the Centre for Eye Research Ireland, looked at the efficacy and safety of atropine eye drops in children aged 6 to 16 with mild myopia (≤ −0.50 diopters). The study, published online in JAMA Ophthalmology, focused on data from 199 children across Europe, with a mean age of 13.9 years, of whom 60.8% were girls.
The MOSAIC trial compared two groups: one group received nightly 0.05% atropine drops for one year after two years of placebo treatment, while the other group received nightly 0.01% atropine drops for two years, followed by a tapering schedule with either placebo or 0.01% atropine. The primary outcomes were myopia progression and axial elongation from months 24 to 36, measured by cycloplegic refraction and axial length.
Key Findings:
Children in the placebo-first group, followed by 0.05% atropine, experienced significantly less axial elongation than those in the 0.01% atropine followed by tapering groups (P = .04). In contrast, children initially treated with 0.01% atropine showed greater myopia progression (−0.13 D) and axial elongation (0.06 mm) compared to those in the 0.05% atropine group.
The side effects of atropine were notable. Among children using 0.05% atropine, 15% reported blurred near vision and 8% experienced photophobia. By comparison, only 3% in the 0.01% atropine group reported blurred near vision, and none experienced photophobia. Despite these issues, the vast majority of children—92%—completed the 36-month visit, and 81% adhered to the treatment regimen, suggesting that the benefits outweighed the side effects for many participants.
Clinical Implications:
The findings suggest that atropine eye drops, particularly at a 0.05% concentration, can effectively slow the progression of myopia and reduce axial elongation when introduced even after a 2-year delay. The authors noted that “despite the adverse events, the treatment regimen showed substantial efficacy in slowing myopia progression and eye growth over the course of one year.”
Study Limitations:
The study acknowledged several limitations, including the smaller sample sizes in year 3, potential carry-over effects from tapering, and the absence of an untreated control group, which made it difficult to assess rebound myopia. Additionally, the age of participants during the third year may have influenced the detection of rebound progression.
Funding and Disclosures:
The study was funded in part by the Health Research Board, Fighting Blindness Ireland, and Vyluma. Several authors disclosed financial ties to Vyluma and other sources.
This research underscores the importance of exploring treatment options for myopia in children, a growing concern in pediatric eye health. Although side effects remain a consideration, atropine eye drops offer a promising tool in controlling myopia progression and its associated risks.
