Three-Month Interim Analyses of Repeated Low-Level Red-Light Therapy in Myopia Control in Schoolchildren: A Multi-Ethnic Randomized Controlled Trial

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.