Mixed: human observational research and a lab calculation · observational
Ostrin LA et al., Ophthalmic & Physiological Optics 2024; JAMA Ophthalmology 2025; JAMA Ophthalmology 2026; Br J Ophthalmology 2026
Landmark T02 #1, what came after (2): the safety question. Independent work has raised retinal-safety concerns the original trial's OCT/BCVA checks could miss. (1) Ostrin LA & Schill AW, Ophthalmic Physiol Opt 2024 (PMC10922340; read in full) measured two commercial red-light myopia devices (the Sky-n1201a and Future Vision; it did NOT test the Eyerising) and calculated that 3 minutes of continuous viewing can approach or exceed the retinal maximum permissible exposure (MPE); recomputing the landmark's Eyerising device (0.29 mW/4-mm pupil -> 2.31 mW/cm2 -> 0.889 mW over a 7-mm aperture > Class-1 MPE 0.385 mW). It also recounts (a single-patient case report, as described by Ostrin & Schill 2024; original not read - not open access) a 12-year-old whose BCVA fell from 6/6 to 6/9 after 5 months of use with bilateral foveal ellipsoid-zone disruption and 'improved to 6/7.5 three months after' therapy stopped. (2) Liao X et al., JAMA Ophthalmol 2025 (PMC12022868; read in full): among RLRL users vs non-users, paracentral cone density was lower (at 0.3 mm temporal, -2.1 x10^3 cells/mm2; 95% CI -3.68 to -0.59; one-sided P=.003), and 'abnormal low-frequency, high-brightness signals' (drusen-like) near the fovea were more common in users (reported OR 7.23, not reproducible from the paper's printed eye counts: 7/97 vs 1/74 gives OR about 5.7, two-sided Fisher P about 0.14). A published dispute (letter + reply, 2026; abstract/record only) and a 2026 4-device re-evaluation (abstract/record only) have since followed; a 3-year real-world cohort (abstract/record only) reports no BCVA loss and no treatment-duration-dependent full-field ERG change, with a minimal, reversible OCT change in 4 eyes (abstract only); its senior and corresponding author, Mingguang He, is a director and shareholder of Eyerising and a named inventor on related patents (BJO disclosure). Long-term retinal safety is unresolved.
Source: Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Ophthalmology. 2022;129(5):509-519. doi:10.1016/j.ophtha.2021.11.023. PMID 34863776. Published online 2021-12-01. ClinicalTrials.gov NCT04073238.
Verified research card EL-LM-T02-01-d-R7