Effect of Photobiomodulation‑Based LED on Myopia Control in Children: An Exploratory Randomized Clinical Trial
5 affiliations
- 1Shanghai Eye Disease Prevention and Treatment Center/Eye Hospital of Tongji University, National Clinical Research Center for Eye Diseases
- 2Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- 3School of Public Health, Shanghai University of Traditional Chinese Medicine
- 4Department of Ophthalmology, The Affiliated People’s Hospital of Ningbo University/The Eye Hospital of Wenzhou Medical University (Ningbo Branch)
- 5Faculty of Information Technology, Monash University
Abstract
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.
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BibTeX
@article{duan2026effect,
title = {{Effect of Photobiomodulation‑Based LED on Myopia Control in Children: An Exploratory Randomized Clinical Trial}},
author = {Yuye Duan and Ziyi Qi and Feiran Yu and Kaidi Xiang and Haotian Wu and Zhenglin Liu and Wei Feng and Zongyuan Ge and Haidong Zou and Xun Xu and Xiangui He},
journal = {Ophthalmology and Therapy},
year = {2026},
month = sep,
doi = {10.1007/s40123-026-01498-8},
url = {https://doi.org/10.1007/s40123-026-01498-8},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Effect of Photobiomodulation‑Based LED on Myopia Control in Children: An Exploratory Randomized Clinical Trial
AU - Yuye Duan
AU - Ziyi Qi
AU - Feiran Yu
AU - Kaidi Xiang
AU - Haotian Wu
AU - Zhenglin Liu
AU - Wei Feng
AU - Zongyuan Ge
AU - Haidong Zou
AU - Xun Xu
AU - Xiangui He
PY - 2026
DA - 2026/09/01
JO - Ophthalmology and Therapy
DO - 10.1007/s40123-026-01498-8
UR - https://doi.org/10.1007/s40123-026-01498-8
AB - 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.
SN - 2193-8245
SN - 2193-6528
ER -