Three-Year Efficacy And Safety Of Repeated Low-Level Red-Light Therapy For Myopia Control: A Multicentre Real-World Cohort Study

To evaluate the long-term efficacy and safety of repeated low-level red-light (RLRL) therapy for myopia control over three years in real-world clinical settings, and to assess axial length progression, visual function outcomes, and structural retinal safety across varying treatment durations.

Multicentre observational cohort study conducted in three tertiary ophthalmic hospitals in China using electronic medical records. Participants were myopic children and adolescents aged 7–18 years undergoing home-based RLRL therapy alongside spectacle correction in routine clinical practice.

Myopic children receiving RLRL therapy between June 2018 and June 2023 were identified and stratified by treatment duration (≥0.5–1, ≥1–2, ≥2–3 and ≥3 years) using stratified random sampling. Therapy consisted of twice-daily 3-minute sessions (650 nm) delivered via a home desktop device. Outcomes included satisfactory myopia control (annual axial elongation ≤0.10 mm), annual axial length and refractive change, and safety assessment using best-corrected visual acuity, optical coherence tomography, and full-field electroretinography. Regression analyses explored factors associated with treatment response.

Among 362 participants, the satisfactory myopia control rate over ≥3 years was 72.53% (95% CI 62.17–81.37) with mean annual axial elongation of 0.06 mm/year (95% CI 0.03–0.08). Control rates were higher in shorter duration groups but remained clinically meaningful beyond three years. All participants achieved BCVA ≥20/25 with no loss ≥2 lines. Electroretinography parameters showed no treatment-duration-related changes. Minimal reversible OCT ellipsoid zone alterations were observed in four eyes (1.1%) without functional impairment. No serious adverse events were reported.

Repeated low-level red-light therapy demonstrates sustained real-world efficacy in slowing myopia progression over three years with a favourable safety profile. These findings support RLRL as a promising long-term myopia control strategy and provide clinically relevant evidence for integration into routine paediatric refractive management.