Efficacy of repeated red-light laser therapy for myopia control in Australian children: a pilot randomised controlled trial

CLINICAL RELEVANCE: Childhood myopia is increasingly prevalent in routine optometric practice and is associated with a lifetime risk of ocular complications. Clinically acceptable and evidence‐based strategies to slow myopia progression are therefore important for long‐term eye health management across diverse populations. BACKGROUND: To assess the efficacy, feasibility and safety of repeated red‐light laser (RLRL) therapy among multi‐ethnic school‐aged children in Australia. METHODS: Randomised controlled trial. 34 multi‐ethnic children aged 8‐13 years with myopia were enrolled. Participants were randomly assigned to the RLRL therapy with single‐vision spectacles (SVS) group or the SVS group. RLRL therapy was administered for 3 minutes, twice daily for 5 days per week, while SVS group continued routine activities. Assessments were scheduled at baseline and follow‐up visits at 1, 3, 6 & 12 months, with compliance monitoring and safety assessments throughout. Axial length (AL), spherical equivalence refraction (SER) and Optical coherence tomography were conducted. RESULTS: A total of 34 children were randomised to 17 in the RLRL group and 17 in the SVS group. Three children in the RLRL group withdrew due to headache (n = 1) and poor compliance to treatment (n = 2). Adjusted mean changes of 12‐month AL and SER were ‐0.03 (95% CI, ‐0.05 to ‐0.01) mm and 0.08 (95% CI, 0.04 to 0.13) D for RLRL group and 0.12 (95% CI, 0.10 to 0.14) mm and ‐0.20 (95% CI, ‐0.29 to ‐0.10) D for SVS group. No severe adverse events were observed during the study period. CONCLUSION: This pilot study in a non‐Chinese Australian population demonstrated that RLRL therapy may be a promising alternative treatment for myopia control in multi‐ethnic school‐aged children, with no documented functional and structural damages. Further research with a larger cohort is warranted to confirm results and explore the long‐term efficacy and safety of RLRL therapy.