Use of low-dose atropine eyedrops (concentration 0.01%) was no better than placebo at slowing myopia (nearsightedness) progression and elongation of the eye among children treated for two years, according to a randomized controlled trial conducted by the Pediatric Eye Disease Investigator Group (PEDIG) and funded by the National Eye Institute (NEI). The trial aimed to identify an effective way to manage this leading and increasingly common cause of refractive error, which can cause serious uncorrectable vision loss later in life. Results from the trial were published in JAMA Ophthalmology.
Importantly, the findings contradict results from recent trials, primarily in East Asia, which showed a benefit from 0.01% atropine in slowing myopia.
“The overall mixed results on low-dose atropine show us we need more research. Would a different dose be more effective in a US population? 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?” said Michael F. Chiang, M.D., director of the NEI, which is part of the National Institutes of Health.
“The absence of a treatment benefit in our U.S.-based study, compared with East Asian studies, may reflect racial differences in atropine response. The study enrolled fewer Asian children, whose myopia progresses more quickly, and included Black children, whose myopia progresses less quickly compared with other races,” noted the study’s lead co-author, Michael X. Repka, M.D., professor of ophthalmology, Johns Hopkins University.
For the study, 187 children ages 5 to 12 years with low-to-moderate bilateral myopia were randomly assigned to use nightly atropine (0.01%) (125 children) or placebo (62 children) eyedrops for two years. Study participants, their parents, and the eye care providers were masked to the group assignments. Patient care was provided at 12 study center sites throughout the U.S.
After the treatment period, and 6 months after treatment stopped, there were no significant differences between the groups in terms of changes in degree of myopia compared with baseline. Nor were there significant differences in axial length within the two groups when compared with baseline measurements.
“It's possible that a different concentration of atropine is needed for U.S. children to experience a benefit,” noted the study’s other lead co-author, Katherine K. Weise, O.D., professor, University of Alabama at Birmingham. “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.”
Read the full news release from the National Eye Institute (NEI).