Study: Low-Dose Atropine Eye Drops No Better than Placebo for Slowing Myopia Progression
A trial conducted by the Pediatric Eye Disease Investigator Group (PEDIG) and funded by the National Eye Institute (NEI) showed that use of low-dose atropine eye drops (concentration 0.01%) was no better than placebo at slowing myopia progression and elongation of the eye among children treated for 2 years. Results from the trial were published in JAMA Ophthalmology.
The findings contradict results from recent trials, primarily in East Asia, which showed a benefit from 0.01% atropine in slowing myopia, acccording to the NEI.
“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?” Michael F. Chiang, MD, director of the NEI, which is part of the National Institutes of Health, said in an NEI news release.
Much stronger concentrations of atropine eyedrops (0.5-1.0%) have long been used by pediatric eye doctors to slow myopia progression. While effective, such doses cause light sensitivity and blurry near vision while on the nightly eye drops. Thus, there is interest in clinical studies assessing lower concentrations that have been shown to have fewer side effects.
“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, said Michael X. Repka, MD, 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) eye drops for 2 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, OD, 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.”
Among children, myopia will stabilize in about half of children around age 16 years, and among an increasingly larger percentage as they get older. By their early twenties, about 10% of individuals with myopia will continue to grow more nearsighted, and by age 24 years that percentage is 4%.
“Vision scientists may help us figure out what’s different about the myopic eye, even among different races and ethnicities, to help create new treatment strategies,” Dr. Weise said. It will take a real convergence of eye research to solve the environmental, genetic, and structural mystery of myopia.”
PEDIG is a collaborative network of pediatric ophthalmologists and pediatric optometrists dedicated to conducting multicenter trials on eye disorders that affect children. The trial was funded by the NEI grants EY11751, EY18810 and EY23198. The ClinicalTrials.gov identifier is NCT03334253.
Reference:
Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA, on behalf of the Pediatric Eye Disease Investigator Group. “Randomized trial of low-dose atropine eyedrops for myopia control”, published July 13, 2023 in JAMA Ophthalmology. doi:10.1001/jamaophthalmol.2023.2855