Purpose: To assess the efficacy and safety of repeated low-level red-light (RLRL) therapy in controlling myopia progression among multi-ethnic school-aged children. This report focuses on 3-month interim analysis. Design: Multi-ethnic, parallel controlled randomized trial Participants: A total of 34 children aged 8-13 years with myopia of cycloplegic spherical equivalent (SE) of − 0.50 to − 5.00 (inclusive) diopters (D), astigmatism of 2.50 D or less, anisometropia of 1.50 D or less, and monocular best-corrected visual acuity (BCVA) of 20/20 or better were enrolled. Methods: Participants were randomly assigned to the RLRL group (n = 16) or the single-vision spectacles (SVS) group (n = 18). RLRL therapy was administered twice daily on weekdays for 3-minute sessions, while the SVS group continued routine activities. Assessments were scheduled at baseline and follow-up visits at 1, 3, 6, and 12 months, with compliance monitoring and safety assessments throughout. Main Outcome Measures: The primary outcome and a key secondary outcome included axial length (AL) change and cycloplegic spherical equivalent (SE) change. Results: A total of 31 (91.2%) participated in the 3-month follow-up visit. The RLRL group demonstrated a significant shortening in AL (-0.07 ± 0.07 mm) compared to the SVS group (0.03 ± 0.05 mm, P<0.001). Similarly, SE progression was hyperopic shift in the RLRL group (0.26 ± 0.14 D) while the SVS group exhibited a myopic shift (-0.03 ± 0.38 D, P=0.009). No severe adverse events were reported. Conclusions: The 3-month interim analysis shows that the efficacy of RLRL therapy in controlling myopia progression among multi-ethnic children is comparable to, or even better than, that idenfied in Chinese patients in previous trials.

The authors have declared no competing interest.

ACTRN12622000526774p

This work was supported by Eyernising international.

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The study protocol was approved by the Ethics Committee of The Royal Children's Hospital (Identifier, HREC 82296), and adhered to the tenets of the Declaration of Helsinki.

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Data will be made available upon reasonable request. To request access, please contact the corresponding author (ndeen@aco.org.au).