As pointed out many times on this and other websites, myopia is an increasingly common global health issue. Although therapies exist to slow the progression of myopia, there is a large growing body of evidence showing a huge rise in the prevalence of the condition. The visual prognosis for many high myopes is not encouraging.
One of the seemingly more promising therapies is RLRLhttps://www.myopiafocus.org/red-light-therapy (repeated low-level red-light therapy).
This involves children looking into a device which emits a very bright red laser light into the eye for several minutes, usually twice a day. This is done most days of the week for many months or even years. Myopia progression has been slowed significantly in many cases.
China’s Crackdown on Red Light Therapy
In recent years, as data and studies have emerged, we have reported on the potential benefits of this therapy. However, we have also written about reported safety issues with RLRL. At least one of these reports was perhaps misinterpreted, but, overall, there has been perhaps too much ‘noise’ around the safety of a device that children could be using regularly. Although manufacturers claim the laser is low energy, there is concern that it could be harmful.
RLRL was previously classed as a Class II medical device in China (where the devices have generally been manufactured). However, recently, RLRL has been changed to a Class III medical device1.
This means that any products using RLRL for myopia management must now go through rigorous and highly complex testing, including pre-clinical assessments on primates before major clinical trials can then be undertaken. At present, no such devices have gone through this process, so, for now, in China at least, RLRL can no longer be legally used.
We are not aware of specific regulatory changes in other countries yet, but it is highly likely that RLRL products will receive similar stronger controls on them in most other countries soon.
Also of concern is the possibility of what is termed ‘rebound’, when myopia therapies are halted suddenly, and rapid growth of the eye occurs. For those children using RLRL, often in combination with other therapies, they and their parents should seek advice from their eye care providers to engage in alternative myopia therapies, like low dose Atropine and Ortho-K contact lenses (night lenses).
References:
Wang YX, Wang N, Wong TY. Red Light Therapy for Myopia—Current Regulatory Changes in China. JAMA Ophthalmol. Published online January 23, 2025. doi:10.1001/jamaophthalmol.2024.5977
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