A recent trial conducted by the Pediatric Eye Disease Investigator Group (PEDIG) and funded by the National Eye Institute (NEI) has revealed unexpected results regarding the effectiveness of low-dose atropine eyedrops (0.01%) in slowing the progression of myopia (nearsightedness) in children over a two-year period. The findings challenge previous studies primarily conducted in East Asia and suggest that there may be racial differences influencing the response to atropine. These results highlight the urgent need for further research to effectively manage this increasingly common eye condition.
The trial, funded by the National Eye Institute (NEI) as part of the Pediatric Eye Disease Investigator Group (PEDIG), involved a randomized controlled study spanning two years. The study examined the impact of low-dose atropine eyedrops with a concentration of 0.01% compared to a placebo in slowing down the progression of myopia in children. Surprisingly, the trial found no significant difference between the two groups, contradicting recent studies in East Asia that suggested the efficacy of 0.01% atropine in decelerating myopia.
According to the trial’s results published in JAMA Ophthalmology, the use of low-dose atropine eyedrops (0.01% concentration) did not prove superior to a placebo in slowing the progression of myopia and the elongation of the eye among children treated for two years. This randomized controlled trial aimed to identify an effective approach to manage this prevalent cause of refractive error, which can lead to irreversible vision loss in adulthood. The findings also contrast with previous trials in East Asia, which demonstrated the benefits of 0.01% atropine in slowing myopia.
“These mixed results regarding low-dose atropine emphasize the need for further research. Could a different dosage be more effective in a US population? Could combining atropine with other strategies produce a synergistic effect? Can we develop alternative treatment or prevention approaches based on a deeper understanding of the causes of myopia progression?” commented Michael F. Chiang, M.D., director of the NEI, which is part of the National Institutes of Health.
Given the rising prevalence of myopia and the risk of it progressing to high myopia, it is crucial to identify an optimal approach for preventing advanced myopia. Predictions indicate that by 2030, 39 million people in the U.S. will have myopia, increasing to 44 million by 2050, representing 50% of the global population.
Higher concentrations of atropine eyedrops (ranging from 0.5% to 1.0%) have long been utilized by pediatric eye doctors to slow the progression of myopia. Although effective, these doses often result in light sensitivity and blurry near vision when using the drops at night. Consequently, there is interest in conducting clinical studies to evaluate lower concentrations, which have shown fewer side effects.
“The absence of treatment benefits in our U.S.-based study, compared to studies in East Asia, might be attributed to racial differences in the response to atropine. The study included fewer Asian children, whose myopia progresses more rapidly, as well as Black children, whose myopia progresses at a slower pace compared to other races,” stated Michael X. Repka, M.D., professor of ophthalmology at Johns Hopkins University and lead co-author of the study.
During the study, 187 children aged 5 to 12 years with low-to-moderate bilateral myopia were randomly assigned to receive nightly atropine (0.01%) (125 children) or placebo (62 children) eyedrops for two years. The study was conducted at 12 research centers across the United States, and the group assignments were concealed from the participants, their parents, and the eye care providers.
At the end of the treatment period and six months after discontinuation, there were no significant differences between the two groups in terms of changes in the degree of myopia compared to the baseline measurements. Similarly, no significant differences were observed in axial length between the two groups and their respective baseline measurements.
“It is possible that a different concentration of atropine is necessary for U.S. children to experience the benefits. Clinical researchers could explore new pharmaceuticals and special wavelengths of light in combination with optical strategies, such as specialized glasses or contact lenses, to determine their effectiveness in reducing myopia progression,” suggested Katherine K. Weise, O.D., professor at the University of Alabama at Birmingham and the study’s other lead co-author.
In children, myopia tends to stabilize in about half of the individuals around the age of 16, with a larger percentage experiencing stability as they grow older. However, about 10% of people with myopia will continue to become more nearsighted into their early twenties, and this percentage decreases to 4% by the age of 24.
“We rely on vision scientists to help us understand the differences in myopic eyes, including variations across different races and ethnicities, to develop new treatment strategies,” added Weise. Solving the environmental, genetic, and structural mysteries of myopia will require a convergence of eye research efforts.
Reference: “Randomized trial of low-dose atropine eyedrops for myopia control” by 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, 13 July 2023, JAMA Ophthalmology.
The Pediatric Eye Disease Investigator Group (PEDIG) is a collaborative network of pediatric ophthalmologists and pediatric optometrists dedicated to conducting multi-center trials focusing on eye disorders affecting children. The trial was funded by NEI grants EY11751, EY18810, and EY23198, with the ClinicalTrials.gov identifier NCT03334253.
Frequently Asked Questions (FAQs) about myopia progression
What did the study by the Pediatric Eye Disease Investigator Group reveal about the effectiveness of low-dose atropine eyedrops in slowing myopia progression?
The study found that low-dose atropine eyedrops (0.01% concentration) were not more effective than a placebo in slowing myopia progression in children over a two-year period. This contradicts previous trials primarily conducted in East Asia that suggested the efficacy of 0.01% atropine.
What implications do the findings have on managing myopia?
The findings highlight the need for further research to effectively manage myopia, as the results contradict previous studies. The study underscores the urgency of identifying optimal approaches for preventing high myopia, given the increasing prevalence of the condition.
Are there racial differences that influence the response to atropine?
The study suggests that racial differences may influence the response to atropine. The enrollment of fewer Asian children, who experience more rapid myopia progression, and inclusion of Black children, who experience slower progression, compared to other races, may contribute to the contrasting results between this study and previous trials conducted in East Asia.
What are the predicted future trends for myopia prevalence?
By 2030, it is predicted that 39 million people in the U.S. will have myopia, and this number is expected to reach 44 million by 2050, representing 50% of the global population. These projections emphasize the importance of finding effective strategies to manage and prevent myopia.
What other research avenues can be explored based on these findings?
The study suggests the need for evaluating different concentrations of atropine to determine if a different dosage could be more effective for children in the United States. Additionally, researchers could investigate combining atropine with other strategies or developing alternative treatment approaches based on a better understanding of the causes of myopia progression.
More about myopia progression
- Study: Randomized trial of low-dose atropine eyedrops for myopia control (JAMA Ophthalmology)
- National Eye Institute (NEI)
- Pediatric Eye Disease Investigator Group (PEDIG)
- ClinicalTrials.gov identifier: NCT03334253