June 3, 2024
By Eman Ali Alzghoul, PhD candidate at the School of Optometry and Vision Science, University of New South Wales
Myopia has become a growing public health concern worldwide, with an increasing number of individuals, particularly children, being affected.1 As the prevalence of myopia continues to rise, the need for effective methods to control its progression has become increasingly important. Low-dose atropine eye drops have emerged as a promising pharmacological agent in the fight against myopia progression, demonstrating efficacy in slowing down myopia in children.2,3 While numerous studies have investigated the efficacy and safety of low-concentration atropine for the control of myopia progression in Asian populations, there is a significant gap in research regarding the use of this treatment in non-Asian populations, particularly in Europe and North America. The existing differences in behavioral, environmental, epidemiologic, and genetic factors between children in Asian countries and those in other regions necessitate caution when extrapolating outcomes from Asian trials to other populations.
The Myopia Outcome Study of Atropine in Children (MOSAIC) is a three-year, double-masked, randomized controlled trial that investigated the efficacy and safety of 0.01% and 0.05% atropine eye drops in managing myopia progression in predominantly white, European children aged 6-16 years. Participants were recruited with spherical equivalent refractive error (SE) ≤ −0.50 D in both eyes. This paper presents results from the initial two-year phase comparing 0.01% atropine to placebo eye drops. SE and axial length (AL) were evaluated at baseline and every six months.
After 24 months, the atropine and placebo groups showed no statistically significant difference in SE change (+0.10 D, p = 0.07). However, the atropine group demonstrated a significantly reduced AL growth compared to the placebo group, with a mean difference of −0.07 mm (p = 0.009). Moreover, the efficacy of 0.01% atropine was significantly higher in white participants and those with lighter-colored eyes, particularly blue, compared to non-white participants and those with brown eyes.
The study also provided valuable insights into the impact of the COVID-19 pandemic on myopia progression. Among all participants in the MOSAIC trial, children recruited after the COVID-19 restrictions were lifted showed the greatest treatment effect with 40% less refractive progression and 32% less axial elongation compared to their untreated counterparts.
The key findings from the MOSAIC study highlight the effectiveness of 0.01% atropine in slowing myopia progression. Moreover, participants tolerated the treatment well, with only a minority experiencing mild discomfort from the eye drops. Interestingly, the study revealed variations in treatment efficacy based on ethnicity, eye color, and potentially the extent of exposure to COVID-19 restrictions during the trial. Also, this paper has suggested that effective myopia management may require an effective therapeutic intervention and optimal behavioral modification.
Abstract
Myopia Outcome Study of Atropine in Children: Two-Year Result of Daily 0.01% Atropine in a European Population
James Loughman, Emmanuel Kobia-Acquah, Gareth Lingham, John Butler, Ekaterina Loskutova, David A Mackey, Samantha S Y Lee, Daniel I Flitcroft
Purpose: The Myopia Outcome Study of Atropine in Children (MOSAIC) is an investigator-led, double-masked, randomized controlled trial investigating the efficacy and safety of 0.01% atropine eye drops for managing myopia progression in a predominantly White, European population.
Methods: Children aged 6–16 years with myopia were randomly allocated 2:1 to nightly 0.01% atropine or placebo eye drops in both eyes for 2 years. The primary outcome was cycloplegic spherical equivalent (SE) progression at 24 months. Secondary outcomes included axial length (AL) change, safety and acceptability. Linear mixed models with random intercepts were used for statistical analyses.
Results: Of 250 participants enrolled, 204 (81.6%) completed the 24-month visit (136 (81.4%) treatment, 68 (81.9%) placebo). Baseline characteristics, drop-out and adverse event rates were similar between treatment and control groups. At 24 months, SE change was not significantly different between 0.01% atropine and placebo groups (effect = 0.10 D, p = 0.07), but AL growth was lower in the 0.01% atropine group, compared to the placebo group (−0.07 mm, p = 0.007). Significant treatment effects on SE (0.14 D, p = 0.049) and AL (−0.11 mm, p = 0.002) were observed in children of White, but not non-White (SE = 0.05 D, p = 0.89; AL = 0.008 mm, p = 0.93), ethnicity at 24 months. A larger treatment effect was observed in subjects least affected by COVID-19 restrictions (SE difference = 0.37 D, p = 0.005; AL difference = −0.17 mm, p = 0.001)
Conclusions: Atropine 0.01% was safe, well-tolerated and effective in slowing axial elongation in this European population. Treatment efficacy varied by ethnicity and eye colour, and potentially by degree of COVID-19 public health restriction exposure during trial participation.
Loughman, J., Kobia‐Acquah, E., Lingham, G., Butler, J., Loskutova, E., Mackey, D. A., … & Flitcroft, D. I. (2024). Myopia outcome study of atropine in children: two‐year result of daily 0.01% atropine in a European population. Acta Ophthalmologica, 102(3), e245-e256.
DOI: https://doi.org/10.1111/aos.15761
References
- Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, et al. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021;62(5):6-.
- Lanca C, Pang CP, Grzybowski A. Effectiveness of myopia control interventions: A systematic review of 12 randomized control trials published between 2019 and 2021. Front Public Health. 2023;11:1125000.
- Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, et al. Interventions for myopia control in children: a living systematic review and network meta‐analysis. Cochrane Database Syst Rev. 2023(2).