The Eyerising Myopia Management Device in use

The authors of a US study have called into question the safety of using two companies’ repeated low-level red light (RLRL) devices for children, sparking rebuttals from one, Eyerising lnternational.

Writing in JAMA Ophthalmology, Drs Lisa Ostrin and Alexander Schill, University of Houston College of Optometry, said their study consisted of a laboratory-based evaluation of the Sky-n1201, Future Vision, Eyerising and AirDoc instruments. They found the Sky-n1201 and Eyerising devices reached American National Standards Institute (ANSI) group 1 limits within exposure times of 2.8 and 1.4 seconds, respectively – well below the recommended 180-second treatment time. They classified them as Class 1 and 2M laser devices, respectively. The Future Vision device only reached group 1 limits under extended exposure times of 253 seconds or longer but remained within Class 1 laser limits. The LED-based AirDoc produced diffuse illumination and remained well within the group 1 limit of at 22,761 seconds’ (over six hours) exposure, they said.

Drs Ostrin and Schill said the results suggest laser-based red-light therapy instruments used for the recommended duration deliver irradiance levels exceeding ANSI safety limits. “These findings, combined with emerging clinical reports of retinal damage and recent regulatory reclassification of red laser devices as Class III in China, highlight the need for rigorous, independent safety validation before widespread paediatric use,” they wrote.

The researchers previously challenged the safety of the Sky-n1201 and Future Vision devices in a separate study published in Ophthalmic & Physiological Optics in 2024. Although the Eyerising Myopia Management Device (EMMD) was not part of that study, its mention in the introduction prompted Eyerising to refute the authors’ claims at the time, alleging several inaccuracies in their study.

In response to the new study, a statement from Professor Mingguang He, chief medical officer of Eyerising International, pointed out that ANSI laser standards were primarily developed for accidental exposure scenarios and hazard classification. They are intentionally conservative and do not directly evaluate therapeutic laser exposure while treating patients, he said. “Accurate safety assessment also requires consideration of clinical usage parameters, including treatment protocols, pupil dynamics, and biologically established injury thresholds.” Further, Drs Ostrin and Schill evaluated laboratory hazard modelling rather than clinical outcomes, he said.

According to independent “world-renowned ophthalmology laser safety experts” Professor John Marshall and Dr Karl Schulmeister, the risk of using the EMMD is negligible when used according to instructions, said Prof He. “Therapeutic exposure from EMMD (~1mW for 3 minutes) is more than 25 times lower than exposure levels shown to be tolerated in human retinal safety studies. The red wavelengths used in RLRL (650–655nm) have minimal photochemical toxicity compared with shorter wavelengths and physiological pupil constriction during treatment reduces retinal exposure compared with worst-case laboratory assumptions."

More than 110,000 individuals have undergone EMMD treatment with no confirmed permanent vision-threatening retinal injury when applied according to protocol, said Prof He. The company also pointed out that the EMMD has already met quality, safety and efficacy standards as required by medical regulators in more than 30 countries across Europe and the Asia-Pacific.

The Class III classification of red-light therapy devices in China cited by the study’s authors reflects regulatory standardisation by the NMPA [National Medical Products Administration], he said. “This is applicable for several devices, including orthokeratology lenses. This change does not indicate new clinical safety concerns regarding EMMD and has no impact on regulatory approval for EMMD internationally,” he said.