Three-Month Interim Analyses of Repeated Low-Level Red-Light Therapy in Myopia Control in Schoolchildren: A Pilot 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 interim three-month data analysis.

Methods: A multi-ethnic, parallel controlled randomized trial. Thirty-four children aged 8-13 years with myopia were enrolled. Participants were randomly assigned to the RLRL group (n = 17) or the single-vision spectacles (SVS) control group (n = 17). RLRL therapy was administered twice daily on weekdays for three-minute sessions, while the SVS group continued routine activities. Assessments were scheduled at baseline and follow-up visits at one, three, six and 12 months, with compliance monitoring and safety assessments throughout. Respectively the primary outcome and a key secondary outcome are axial length (AL) change and cycloplegic spherical equivalent (SE) change.

Results: A total of 32 (94.1%) participated in the three-month follow-up visit. The RLRL group demonstrated a significant shortening in AL ( - 0.06   ±   0.05 mm) compared to the SVS group (0.02   ±   0.06 mm, p < 0.001). Similarly, the RLRL group demonstrated a reversal in SE (0.23   ±   0.18 D), whereas the SVS group exhibited a smaller increase (0.04   ±   0.43 D). No severe adverse events were reported in either of the groups.

Conclusions: The three-month interim analysis shows that RLRL therapy effectively controls myopia progression among multi-ethnic children without safety concerns, suggesting its potential as a globally applicable solution for myopia control.