Low-Dose Atropine Eye Drops Did Not Slow Myopia Progression, New Study Finds

Michael F. Chiang, MD

Credit: National Eye Institute

New research suggests the use of nightly low-dose atropine eyedrops (0.01%) did not slow the progression of myopia or axial elongation, compared with placebo, among children in the United States treated over a 2-year period.¹

Results from the randomized controlled trial (RCT) were opposed to previously reported findings from trials in East Asia, which suggested a benefit from 0.01% atropine in slowing myopia progression.

“The overall mixed results on low-dose atropine show us we need more research,” Michael F. Chiang, MD, director of the National Eye Institute (NEI), part of the National Institutes of Health, said in a statement.² “Would combining atropine with other strategies have a synergistic effect? Could we develop other approaches to treatment or prevention based on a better understanding of what causes myopia progression?”

An optical approach to the prevention of high myopia is needed, given the surging prevalence of the vision condition worldwide and the risk of its progression to the advanced stage. It is projected by 2030, 39 million people in the United States will have myopia. By 2050, the number is expected to grow to 44 million in the United States and 50% of the global population.

Atropine eye drops at more substantial concentrations (0.5% - 1.0%) have been used for decades by pediatric ophthalmologists and optometrists to slow myopia progression. These concentrations appeared effective but were associated with photophobia and near blur, reducing their acceptance. RCTs of low-dose atropine to slow myopia progression have typically been conducted in East Asia, with no published results from large trials in the US.

The current study reported the efficacy and safety of 1 drop of atropine, 0.01%, nightly compared with placebo at slowing myopia progression over 2 years in US children aged 5 - 12 years, with an assessment of myopia progression over 30 months. The trial was conducted from June 2018 - September 2022. Children were randomly assigned 2:1 to 1 eye drop of atropine 0.01% or 1 eye drop of placebo nightly for 24 months, followed by 6 months without eye drops.

A total of 187 children (mean age, 10.1 years; 101 females [54%]) with an age range of 5 - 12 years were included in the study: 125 (67%) children received atropine, 0.01%, and 62 children (33%) received placebo. A 24-month follow-up was completed by 119 of 125 children (95%) in the atropine group and 58 of 62 children (94%) in the placebo group; a 30-month follow-up was completed by 118 of 125 children (94%) in the atropine group and 57 of 62 children (92%) in the placebo group.

After treatment, and 6 months after treatment was stopped, the analysis showed no significant differences between groups regarding the change in degree of myopia compared with baseline. At the 24-month primary endpoint, data showed the adjusted mean change in spherical equivalent refractive error (SER) from baseline was –0.82 D (95% CI, –0.96 to –0.68) and –0.80 D (95% CI, –0.98 to –0.62) in the atropine and placebo groups, respectively.

Investigators additionally observed no significant differences in axial length in the 2 groups compared with baseline measurements. The adjusted mean changes in axial length from baseline to 24 months were 0.44 mm (95% CI, 0.39 - 0.50) and 0.45 mm (95% CI, -.37 - 0.52) in the atropine and placebo groups, respectively. The adjusted difference in mean axial elongation from baseline to 30 months was +0.009 mm (95% CI, -0.115 to 0.134 mm).

“The absence of a treatment benefit in our US-based study, compared with East Asian studies, may reflect racial differences in atropine response,” Michael X. Repka, MD, the study’s co-lead author and a professor of ophthalmology at Johns Hopkins University said in a statement.² “The study enrolled fewer Asian children, whose myopia progresses more quickly, and included Black children, whose myopia progresses less quickly compared with other races.”

The investigative team noted that vision specialists might need to determine the difference in the myopia eye among different races and ethnicities to create new, effective treatment strategies.

“It’s possible that a different concentration of atropine is needed for US children to experience a benefit,” Katherine K. Weise, OD, the study’s co-lead author and a professor at the University of Alabama at Birmingham said in a statement.² “Clinical researchers could evaluate new pharmaceuticals and special wavelengths of light in combination with optical strategies, like special glasses or contact lenses, to see what works in reducing the progression of myopia.”

References

1. Repka MX, Weise KK, Chandler DL, et al. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial . JAMA Ophthalmol. Published online July 13, 2023. doi:10.1001/jamaophthalmol.2023.2855
2. Nateyeinstitute. Low-dose atropine eyedrops no better than placebo for slowing myopia progression. EurekAlert! July 13, 2023. Accessed July 13, 2023. https://www.eurekalert.org/news-releases/995227.