2024 March ; 44(2): 241–248 | Lisa A Ostrin, Alexander W Schill
The study evaluates the safety of low-level red light (LLRL) devices used for myopia control in children. Two LLRL devices, the Sky-n1201a and Future Vision, were characterized for their output and maximum permissible exposure (MPE) to assess thermal and photochemical risks. Both devices were confirmed to be Class 1 laser products. The Sky-n1201a delivered a 654 nm wavelength, 0.2 mW power, 1.17 mW/cm² corneal irradiance, and 7.2 W/cm² retinal irradiance. The MPE for photochemical damage is 0.55–7.0 seconds for 2–7 mm pupils, and for thermal damage is 0.41–10 seconds for 4.25–7 mm pupils. The Future Vision delivered a 652 nm wavelength, 0.06 mW power, 0.624 mW/cm² corneal irradiance, and 0.08 W/cm² retinal irradiance. The MPE for photochemical damage is 50–625 seconds for 2–7 mm pupils. Continuous viewing of both devices for three minutes exceeds the MPE, posing a risk of photochemical and thermal damage to the retina. The study recommends that clinicians reconsider the use of LLRL therapy for myopia in children until safety standards are confirmed.The study evaluates the safety of low-level red light (LLRL) devices used for myopia control in children. Two LLRL devices, the Sky-n1201a and Future Vision, were characterized for their output and maximum permissible exposure (MPE) to assess thermal and photochemical risks. Both devices were confirmed to be Class 1 laser products. The Sky-n1201a delivered a 654 nm wavelength, 0.2 mW power, 1.17 mW/cm² corneal irradiance, and 7.2 W/cm² retinal irradiance. The MPE for photochemical damage is 0.55–7.0 seconds for 2–7 mm pupils, and for thermal damage is 0.41–10 seconds for 4.25–7 mm pupils. The Future Vision delivered a 652 nm wavelength, 0.06 mW power, 0.624 mW/cm² corneal irradiance, and 0.08 W/cm² retinal irradiance. The MPE for photochemical damage is 50–625 seconds for 2–7 mm pupils. Continuous viewing of both devices for three minutes exceeds the MPE, posing a risk of photochemical and thermal damage to the retina. The study recommends that clinicians reconsider the use of LLRL therapy for myopia in children until safety standards are confirmed.