Retinal Safety Assessment Of A Repeated Low-Level Red-Light Laser Device For Myopia Management: Laboratory Measurement And Injury-Threshold Modelling
Published 2026 - 44th Congress of the ESCRS
Reference: FP23.12 | Type: Free paper | DOI: 10.82333/7492-fb18
Authors: Prof. John Marshall* 1 , Dr Karl Schulmeister 2 , Dr Sanil Joseph 3
1UCL Institute of Ophthalmology,University College of Londond,London,United Kingdom, 2Seibersdorf Labor GmbH,Seibersdorf,Austria, 3Ophthalmic Epidemiology,Centre for Eye Research Australia,Melbourne,Australia;Medical Affairs,Eyerising International ,Melbourne,Australia
Purpose
Repeated low-level red-light (RLRL) therapy is increasingly used for myopia control in children; however, recent reports have raised retinal safety concerns. This study evaluated retinal safety of the Eyerising Myopia Management Device (EMMD) by measuring emission parameters under worst-case conditions and comparing exposures with established thermal and photochemical injury thresholds and human volunteer data.
Setting
Laboratory-based device safety evaluation conducted in an accredited optical radiation testing facility (Seibersdorf Labor GmbH, Austria), with analytical comparison to published retinal injury threshold datasets and human exposure studies.
Methods
Two EMMD devices were assessed under worst-case conditions. Wavelength, power output, and retinal image characteristics were measured using spectrometry, integrating sphere power measurements, and CCD beam profiling with an artificial eye model. Exposure levels were compared with IEC laser classification limits, maximum permissible exposure (MPE) values, and experimentally derived thermal injury thresholds using validated computational modelling. Photochemical hazard additivity and repair kinetics were analysed for repeated daily exposures.
Results
EMMD emitted radiation at 654–655 nm with intraocular power ≈1 mW through a 7 mm pupil, placing the device in laser Class 3R but marginally above Class 2 limits. Corneal irradiance (~26 W m⁻²) remained well below conservative photochemical MPE limits. Thermal injury modelling predicted retinal damage thresholds substantially above device exposure levels, even under stationary worst-case assumptions. Comparison with human volunteer data involving higher power exposures revealed no objective or subjective retinal injury, providing an additional empirical safety margin.
Conclusions
Measured emission parameters, injury-threshold modelling, and empirical exposure data demonstrate that EMMD operates within conservative retinal safety margins under prescribed treatment protocols. These findings support the safe clinical application of RLRL therapy when delivered using controlled exposure regimens while emphasising continued monitoring in photosensitive individuals.