Offering low-dose atropine (LDA) as a therapy for myopia control in the UK faces several key challenges, even though it has shown significant promise in studies across various populations. Some of the issues include:
Limited Regulatory Approval
Currently, low-dose atropine (LDA), particularly concentrations like 0.01% or 0.05%, is not yet widely approved as an official treatment for myopia in the UK. The treatment remains off-label, which complicates its prescription. Optometrists may be hesitant to recommend or prescribe it without formal approval from regulatory bodies like the National Institute for Health and Care Excellence (NICE) or the Medicines and Healthcare products Regulatory Agency (MHRA). Also, unless clinicians have an IP post graduate qualification, they may be unwilling or unable to offer LDA without indemnity insurance issues.
Lack of Local Clinical Data
Most of the evidence supporting the efficacy of LDA in controlling myopia progression has come from East Asian studies, where genetic, environmental, and lifestyle factors may differ significantly from those in the UK population (particularly the genetic factors). For example, trials like the ATOM studies in Singapore and other similar research have largely focused on Asian populations, which tend to have higher rates of myopia.
The applicability of this data to children in the UK remains under-researched, though trials like the ongoing CHAMP-UK study aim to address this gap1.
Early data suggests that LDA is effective, but UK-specific results are still emerging.
Ethnic and Environmental Differences
Myopia progression rates and the response to treatments like LDA may vary across ethnic groups. For instance, in European children, the efficacy of LDA has been found to be slightly less pronounced compared to Asian populations2.
There are also differences in outdoor activity levels, education systems, and screen time that could influence both the onset and progression of myopia, as well as the effectiveness of LDA as a treatment.
One example of this is something I raised in a CPD webinar some years ago. I looked at what I called ‘the perfect myopia storm’. I imagined a child growing up in Seoul in South Korea. Both the child’s parents are myopes. They live in a crowded city district with little access to daylight and outdoor time. The child works hard at school (where much of the learning uses computers and tablets and close work) and she goes to ‘cram’ school in the evenings where she also uses computers. The child has had access to smartphones, tablets, computers and tech since being a baby. The child has siblings with myopia. The child had their first myopic spectacle prescription at 3 years of age. The child’s grandparents and great grandparents were myopic and had high myopia with MMD in two of them. The child uses computers and watches the TV late into the night, with no red or orange lighting. Everything the child views is high contrast and close. This child even has accommodative lag.
You can see how both the genetic predisposition as well as extreme lifestyle factors may be much different than a similar child living in rural Korea. Now imagine the difference in risk compared to a Caucasian child in the UK living in a rural area and one that spends a lot of time outdoors and much less time doing homework, study, and using a smartphone, for example.
Cost and Access
Currently, LDA therapy is not available as an over-the-counter treatment in the UK, which limits its accessibility. Parents would need to seek private prescriptions if available at all in the UK, which could make the treatment expensive and inaccessible for a broader segment of the population. This could lead to inequities in access to effective myopia control therapies.
Long-Term Safety Concerns
Although low-dose atropine has been shown to have fewer side effects than higher concentrations, long-term safety data in European populations is still limited. Concerns around potential rebound effects (i.e., an increase in myopia progression after discontinuation of treatment) and any long-term impacts on vision or ocular health remain areas that need further study3.
Awareness and Acceptance by Practitioners
Many optometrists and ophthalmologists in the UK are not yet fully familiar with LDA for myopia control, and there is limited guidance on how it should be integrated into standard care pathways. There is no readily available licenced and accepted form of LDA in the UK at present for general optometry use. Training and education would be required to ensure that LDA is offered appropriately and with proper monitoring of its effects and may require an IP qualification and perhaps even further indemnity insurance.
Conclusion
While LDA shows significant potential as a therapy for controlling myopia progression, the lack of regulatory approval, limited local data, cost barriers, and the need for longer-term safety studies currently limit its widespread adoption in the UK. With more local trials like CHAMP-UK and broader acceptance by regulatory bodies, LDA could eventually become a standard part of myopia management in the UK.
References
Azuara-Blanco, A., Logan, N., Strang, N., Saunders, K., Allen, P., Weir, R., Doherty, P., Adams, C., Gardner, E., Hogg, R., McFarland, M., Preston, J., Verghis, R., Loughman, J., Flitcroft, I., Mackey, D., Lee, S., Hammond, C., Congdon, N., & Clarke, M. (2019). Low-dose (0.01%) atropine eye-drops to reduce progression of myopia in children: a multicentre placebo-controlled randomised trial in the UK (CHAMP-UK)—study protocol. British Journal of Ophthalmology, 104, 950 - 955. https://doi.org/10.1136/bjophthalmol-2019-314819.
Loughman, J., Kobia-Acquah, E., Lingham, G., Butler, J., Loskutova, E., Mackey, D., Lee, S., & Flitcroft, D. (2023). Myopia outcome study of atropine in children: Two-year result of daily 0.01% atropine in a European population. Acta ophthalmologica. https://doi.org/10.1111/aos.15761.
Chia, A., Lu, Q., & Tan, D. (2016). Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology, 123 2, 391-9. https://doi.org/10.1016/j.ophtha.2015.07.004.
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