Safety Evaluation of 4 Red Light Therapy Devices for Myopia

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Photomedicine

Background:

• Red laser therapy is increasingly used for myopia management, particularly in Asia.
• Concerns exist regarding the ocular safety of commercially available red light therapy devices.
• Limited rigorous evaluation of these devices' optical output and safety classifications has been performed.

Purpose of the Study:

• To evaluate the optical output and safety classification of four commercial red light therapy devices for myopia.
• To assess compliance with American National Standards Institute (ANSI) safety guidelines for these devices.

Main Methods:

• Laboratory-based evaluation of four myopia management devices (Sky-n1201, Future Vision, EyeRising, AirDoc).
• Measurement of radiometric power at specified distances and aperture sizes.
• Calculation of retinal irradiance for various pupil diameters.
• Safety classification according to ANSI Z80.36-2021 and ANSI Z136.1-2022 standards.

Main Results:

• Laser-based devices (Sky-n1201, EyeRising) reached ANSI group 1 safety limits within 1.4 to 2.8 seconds for a 7mm pupil, classified as Class 1 and 2M.
• Future Vision device exceeded extended exposure times but remained Class 1.
• The LED-based AirDoc device had a significantly longer time to reach limits (22,761 seconds), classified as group 1.

Conclusions:

• Laser red light therapy devices may deliver irradiance levels reaching safety limits in exposure times shorter than recommended treatment durations.
• Clinical reports of retinal damage and regulatory actions necessitate independent safety validation for pediatric use.
• Urgent need for rigorous safety assessments of red light therapy devices before widespread adoption.