Effect of Photobiomodulation‑Based LED on Myopia Control in Children: An Exploratory Randomized Clinical Trial.

INTRODUCTION: Laser-based repeated low-level red-light (RLRL) therapy may slow myopia progression, but evidence for lower-intensity noncoherent photobiomodulation-based light-emitting diode (PBM-LED) therapy remains limited. We evaluated its short-term efficacy and safety in children with myopia. METHODS: In this single-center, double-masked, sham-controlled exploratory trial, 40 children aged 8-12 years were randomized 1:1 to PBM-LED or sham treatment twice daily for 3 months. Primary outcomes were axial length (AL) and cycloplegic spherical equivalent (SE). RESULTS: All participants completed follow-up. In eye-specific analyses, the intervention group showed less axial elongation, with significance only in the left eye at 3 months (difference, -0.056 mm; 95% confidence interval, -0.109 to -0.004; P = 0.036). Using participant-level means of both eyes, unadjusted 3-month differences were -0.059 mm for AL (P = 0.061) and 0.244 D for SE (P = 0.092); adjusted differences were not significant. Five eyes across both groups showed a 0.20-logMAR deterioration in uncorrected visual acuity at 3 months, but no eyes showed a 0.20-logMAR or greater decline in best-corrected visual acuity at 1 or 3 months. No serious adverse events or structural retinal abnormalities were observed. CONCLUSIONS: PBM-LED showed a preliminary short-term treatment signal, but the small sample, unilateral nominal finding, nonsignificant adjusted participant-level analyses, visual-acuity changes, and short follow-up preclude definitive efficacy or long-term safety conclusions. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT07375589.