Spotlight - The Future of Cryopreserved Amniotic Membrane in Oculoplastic Surgery
Optometry360 Logo White
Home > Myopia > Lab testing raises safety concerns for red light myopia therapy devices

Lab testing raises safety concerns for red light myopia therapy devices

Ophthalmology 360

Key Takeaways

  1. Two laser-based red light devices reached ANSI safety limits in under 3 seconds.
  2. The LED-based device produced much lower retinal exposure and remained within safety limits for hours.
  3. Standard treatment times exceeded the safe exposure window for some laser devices under laboratory testing.

Some red light myopia devices reached safety exposure limits within seconds, raising concerns about their use at standard treatment times, according to a new study.

Investigators examined Sky-n1201, Future Vision, EyeRising, and AirDoc, all commercially available red light therapy devices marketed for myopia management.

Researchers measured radiometric power at 1- and 10-cm distances through a 7-mm aperture. Retinal irradiance was then calculated for pupil sizes ranging from 2 to 7 mm. Devices were classified based on American National Standards Institute (ANSI) safety guidelines, with the primary outcome being the time required to reach the group 1 safety limit.

The Sky-n1201 and EyeRising devices reached the group 1 safety limit within 2.8 seconds and 1.4 seconds, respectively, for a 7-mm pupil. Based on ANSI criteria, Sky-n1201 was classified as a Class 1 laser device, while EyeRising was classified as Class 2M. The Future Vision device reached group 1 limits only after extended exposure times of ≥253 seconds and met criteria for Class 1 laser classification.

In contrast, the light-emitting diode–based AirDoc device produced diffuse illumination and took 22,761 seconds to reach the group 1 safety limit, placing it in the group 1 classification.

The authors noted that the laser-based devices reached ANSI safety thresholds in exposure times shorter than the commonly recommended 180-second treatment duration. They also referenced emerging clinical reports of retinal damage and the recent regulatory reclassification of red laser devices as Class III in China.

The study emphasizes the need for independent safety testing before these devices are widely used, particularly in children.

Reference
Ostrin LA, Schill AW. Safety Evaluation of 4 Red Light Therapy Devices for Myopia. JAMA Ophthalmol. 2026;doi: 10.1001/jamaophthalmol.2025.5660. Epub ahead of print. PMID: 41642586.

Related Content