Some red light therapy devices may exceed safety levels for myopia control, study suggests

An evaluation of commercially available red light devices used to control myopia found that the devices exceeded established safety levels and may damage vision. The recommended duration for red light therapy is 180 seconds. Authors Lisa A. Ostrin, OD, PhD, and Alexander W. Schill, PhD, from the University of Houston College of Optometry, Houston, called for “rigorous, independent safety validation before widespread pediatric use.” They published their findings as a Brief Report in JAMA Ophthalmology.¹

Ostrin and Schill explained that red light therapy is being considered “a potentially effective intervention for myopia in children.”

Four studies^2-5 have reported that the progression of myopia and axial lengthening decreased significantly and the choroids thickened. Regulatory approval has been granted for the Eyerising Myopia Management Device (Eyerising International) in the UK, Japan, Vietnam, Australia, Columbia, and Ecuador. The device has reportedly been used to treat over 100,000 in China and more than 250,000 session outside of China, according to the company.

Three reports in which the Eyerising device was used to treat children described structural retinal damage with repeated therapy and partial visual recovery,⁶ decreased cone photoreceptor density after a year of therapy,⁷ and structural imaging changes in 7% of children after 1 to 6 months of therapy with potential subclinical/progressive retinal effects.⁸

However, Drs. Ostrin and Schill point out that the ocular safety of these laser-based instruments has not been rigorously established or published.⁹

Red light therapy safety study

The investigators conducted a study in which they assessed the optical output and safety classifications of 4 devices that are currently commercially available according to the American National Standards Institute (ANSI) guidelines.

The four devices that were evaluated were the Sky-n1201 (Beijing Mingren Shikang Science & Technology Co, Ltd), Future Vision (Hunan Medical Technology Co, Ltd), Eyerising Myopia Management Device, and AirDoc Photobiomodulation (Beijing Airdoc Technology Co, Ltd) instruments.

The safety classification was investigated according to ANSI Z80.36-2021 and ANSI Z136.1-2022 standards. The main outcome measure was the time to the group 1 safety limit and the ANSI device classification measured by laboratory-based evaluation of the four instruments and the radiometric power the was measured with various pupillary diameters, the investigators recounted.

What did the evaluation of the devices find?

The investigators reported that “the Sky-n1201 and EyeRising devices reached ANSI group 1 limits within exposure times of 2.8 and 1.4 seconds, respectively, for a 7-mm pupil and are classified as Class 1 and 2M laser devices, respectively. The Future Vision device reached group 1 limits under extended exposure times of 253 seconds or longer but remained within limits for Class 1 laser classification. The light-emitting diode [LED]-based AirDoc produced diffuse illumination with a time to group 1 limit of 22,761 seconds, classifying it as group 1.

Comments on the findings

“These findings raise safety concerns for red light therapy devices. The EyeRising, Sky-n1202, and Future Vision devices produce a highly coherent laser beam, with EyeRising and Sky-n1202 surpassing safe viewing in shorter durations than the 180-second treatment period,” the study authors said.

They went on to explain that the AirDoc LED-based device uses an extended LED light source with an irradiance of 6.9 mW/cm² at the entrance pupil of the eye and the time to the group 1 limit was well above the 180-second recommended treatment duration. “Although this instrument is safe to view for extended durations, to our knowledge, it has not yet been published in clinical trials for efficacy of myopia control,” they said.

The investigators’ primary concern is that this technology is being adopted too rapidly without determination of the devices’ safety. “This quality improvement study found that EyeRising and Sky-n1201 exceeded ANSI laser and ophthalmic instrument safety classifications. We urge eye care professionals, researchers, and regulatory agencies to prioritize safety assessments of these devices, including adaptive optics retinal imaging, multifocal electroretinography, and long-term cohort monitoring, before widespread pediatric use. Establishing a balance between therapeutic efficacy and ocular safety remains essential to ensure that this intervention intended to preserve lifelong vision does not itself pose avoidable risks that outweigh benefits,” they concluded.

References:

1. Ostrin LA, Schill AW. Safety evaluation of 4 red light therapy devices for myopia. JAMA Ophthalmol. 2026; published online February 5. doi: 10.1001/jamaophthalmol.2025.5660

2. Sobol M, Pniewski J. Efficacy of repeated low-level red light (RLRL) therapy in managing childhood myopia: a systematic review and meta-analysis. J Clin Med. 2024;14:14. doi:10.3390/jcm14010083

3. Xuan M, Zhu Z, Jiang Y, et al. Longitudinal changes in choroidal structure following repeated low-level red-light therapy for myopia control: secondary analysis of a randomized controlled trial. Asia Pac J Ophthalmol (Phila). 2023;12:377-83. doi:10.1097/APO.0000000000000618

4. Jiang Y, Zhu Z, Tan X, et al. Effect of repeated low-level red-light therapy for myopia control in children: a multicenter randomized controlled trial. Ophthalmology. 2022;129:509-19. doi:10.1016/j.ophtha.2021.11.023

5. Zhou L, Xing C, Qiang W, Hua C, Tong L. Low-intensity, long-wavelength red light slows the progression of myopia in children: an Eastern China-based cohort. Ophthalmic Physiol Opt. 2022;42:335-44. doi:10.1111/opo.12939

6. Liu H, Yang Y, Guo J, Peng J, Zhao P. Retinal damage after repeated low-level red-light laser exposure. JAMA Ophthalmol. 2023;141:693-5. doi:10.1001/jamaophthalmol.2023.1548

7. Liao X, Yu J, Fan Y, et al. Cone density changes after repeated low-level red light treatment in children with myopia. JAMA Ophthalmol. 2025;143:480-8. doi:10.1001/jamaophthalmol.2025.0835

8. Zhang Z, Hu D, Xu W, Wu T, Gao L, Yang C. Structural OCT changes following repeated low-level red-light therapy for myopia prevention. JAMA Ophthalmol. 2025;143:876-877. doi:10.1001/jamaophthalmol.2025.2767

9. Schaeffel F, Wildsoet CF. Red light therapy for myopia: Merits, risks and questions. Ophthalmic Physiol Opt. 2024;44:801-7. doi:10.1111/opo.13306