An analysis of retinal safety when using a laser based low-level red light therapy device for myopia

PurposeTo evaluate the retinal safety of repeated low-level red-light (RLRL) therapy using the Eyerising Myopia Management Device (EMMD) by analysing exposure parameters relative to established thermal and photochemical retinal injury thresholds and empirical human exposure data. MethodsEmission characteristics of the EMMD were measured in an accredited laboratory under worst-case conditions. Parameters assessed included wavelength, intraocular power, corneal irradiance, and retinal image characteristics across accommodative states. These measurements were compared with international safety standards, maximum permissible exposure limits, and experimentally derived retinal injury thresholds from animal studies and validated computational models. The effects of repeated exposures from RLRL therapy using the EMMD were evaluated using photochemical additivity principles and repair kinetics, and further contextualised using human volunteer exposure data. ResultsThe EMMD emitted red laser radiation at 654-655 nm with a maximum intraocular power of approximately 1 mW through a 7 mm pupil, placing it within Class 3R and marginally above the Class 2 limit. Corneal irradiance was approximately 26 W m- 2, well below conservative photochemical exposure limits. Thermal injury modelling indicated retinal damage thresholds above device exposure, including under worst-case assumptions of minimal retinal image size and absence of eye movements. Accounting for repeated daily exposures and photochemical additivity, safety margins remained approximately 3-fold for a 7 mm pupil and approximately 8-fold for a more realistic 4 mm pupil. Human volunteer studies demonstrated no detectable structural or functional retinal injury at exposure levels approximately five times higher than those produced by the EMMD. ConclusionExposure parameters of RLRL therapy using the EMMD remain well below conservative retinal injury thresholds under prescribed use conditions. Integration of experimental, modelling, and human data indicates substantial safety margins, supporting its safe clinical use.