Experts debate if atropine should be standard of care for myopia control
Key takeaways:
- One presenter said there is sufficient evidence supporting atropine to slow myopia progression.
- Another said inconsistent study designs do not support atropine as the standard of care.
SEVILLE, Spain — Whether atropine should be the standard of care for halting myopia progression was a hot topic discussed at the Congress on Controversies in Ophthalmology.
In favor
Myopia has become a global epidemic and is associated with complications such as myopic macular degeneration, retinal detachment, cataract and open-angle glaucoma.
“We know that slowing myopia progression by only 1 D can significantly reduce the risk of vision-threatening conditions,” Andrzej Grzybowski, MD, PhD, said.
In his opinion, atropine in myopia control is cost-effective and safe, Grzybowski said. In a recent review published in Ophthalmology and Therapy by Eppenberger and colleagues, atropine was shown to have the highest amount of evidence, the best estimated effect and the lower cost per year as compared with spectacles, contact lenses and red light therapy. It also has a high safety profile, second only to spectacles.
The first studies with atropine in myopes date back to 1868, but the modern approach of using low-dose atropine for myopia control started with the ATOM 1 (Chua, et al.) and ATOM 2 (Chia, et al.) studies in Singapore about 20 years ago. These studies showed that low-dose atropine was effective in slowing myopia progression.
In 2019, the LAMP study (Yam, et al.) showed an even higher efficacy with the 0.05% concentration, and 2 years ago, a large randomized controlled trial (Zadnik, et al.) based on 500 participants from 26 sites in six countries confirmed the effectiveness of the lowest concentration, Grzybowski said.
There is good evidence of safety, he said. The ATLAS study (Li, et al.) published in Singapore provided evidence of a low incidence of ocular complications at 10 and 20 years.
Only three studies — MOSAIC (Loughman, et al), WA-ATOM (Lee, et al.) and PEDIG (Repka, et al.) — contradict this large body of evidence, suggesting that atropine has little or no effect, at least in the long term.
“These different outcomes are likely based on some inconsistencies in the formulation of atropine. The use of different preservatives or no preservatives and the pH could account for differences in drug penetration to the eye,” Grzybowski said.
Against
Hakan Kaymak, MD, developed a keen interest in atropine for myopia in the beginning of his career and started using atropine 0.01% in 2017. However, a retrospective analysis of his real-world results (Kaymak, et al.) published in 2021 showed that the effect was not as good as expected.
When looking for the reasons, he found that compliance with the treatment was low.
Only 36% of the children attended all visits, and when looking at the ordered doses, only 367 doses were ordered on average per child, far from the expected 520 doses.
“The compliance was just 70% in real life,” Kaymak said.
Motivation is theoretically high in these children and their parents, but compliance appears to go down within weeks.
“How will compliance be after 10 years? Could this really be the standard of care?” he asked.
In addition, the use of atropine for myopia prevention is still off label, and there is no specific, uniform formulation for this indication.
“The pH values are different. The osmolarity is different. Some formulations contain preservatives and others do not. Therefore, they have different side effects. The drop volume also varies a lot. There are no standards in atropine therapy,” Kaymak said.
Before establishing a standard of care, some fundamental questions need to have evidence-based answers, but this is not yet possible for atropine. To all questions that parents might ask — about dosing, duration of treatment and mechanism of action— there is only one answer: “I don’t know,” he said.
“Would you accept a therapy for your child when every clinical question is answered with ‘I don’t know?’ And if not, should we really call that a new standard of care?” Kaymak said.
Work still needs to be done, starting with defining axial myopia and what differentiates the physiological axial length growth, which is universal across races and ethnicities, from excessive growth.
Studies so far have been inconsistent regarding inclusion and exclusion criteria, age ranges, baseline refraction and axial length ranges, placebo groups, as well as results in terms of reduction in progression, measured in percentages of spherical equivalent and axial length elongation.
“This is the babel of myopia studies,” Kaymak said. With such confusing evidence, “we cannot make a real decision on a standard of care.”
References:
- Chia A, et al. Ophthalmology. 2012;doi:10.1016/j.ophtha.2011.07.031.
- Chua WH, et al. Ophthalmology. 2006;doi:10.1016/j.ophtha.2006.05.062.
- Eppenberger LS, et al. Ophthalmol Ther. 2024;doi:10.1007/s40123-024-00951-w.
- Grzybowski A, et al. Strabismus. 2018;doi:10.1080/09273972.2017.1421675.
- Kaymak H, et al. Graefes Arch Clin Exp Ophthalmol. 2021;doi:10.1007/s00417-021-05254-5.
- Lee SS, et al. Clin Exp Ophthalmol. 2024;doi:10.1111/ceo.14368.
- Li Y, et al. JAMA Ophthalmol. 2024;doi:10.1001/jamaophthalmol.2023.5467.
- Loughman J, et al. Acta Ophthalmol. 2024;doi:10.1111/aos.15761.
- Repka MX, et al. JAMA Ophthalmol. 2023;doi:10.1001/jamaophthalmol.2023.2855.
- Yam JC, et al. Ophthalmology. 2019;doi:10.1016/j.ophtha.2018.05.029.
- Zadnik K, et al. JAMA Ophthalmol. 2023;doi:10.1001/jamaophthalmol.2023.2097.
Collapse
Grzybowski A, et al. Debate 1: Will topical therapy become the standard of care for either prevention or delay of myopia progression? Presented at: Congress on Controversies in Ophthalmology; April 4-5, 2025; Seville, Spain.
Read more about