Six-Month Interim Analyses of the Efficacy of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology for Myopia Control in Spanish Children.

Abstract

Purpose: To evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in combination with orthokeratology (OK) for controlling myopia in Spanish children.

Methods: A single-site, randomized, parallel-group, single-blinded clinical trial. Twenty-six children aged 8-15 years with myopia between -0.75 to -6.75 D were enrolled. Participants were randomly assigned to either the RLRL combined with OK (RCO) group (n = 11) or the OK-only group (n = 15). The OK group wore OK lenses for at least 8 hours per night, while the RCO group received additional daily RLRL therapy, administered twice daily for 3 minutes per session five days per week. Follow-up visits were conducted at 1, 3, 6, and 12 months, with compliance and safety monitoring. The primary outcome measure was axial length (AL) change.

Results: All 26 children completed the 6-month follow-up visit. After 6 months, the adjusted mean AL change was -0.057 mm (95% CI, -0.078 to -0.037 mm) in RCO group, and 0.041 mm (95% CI, 0.029 to 0.054 mm) in OK group. In RCO group, 5 children (45.5%) achieved clinically significant axial shortening (defined as AL change ≤ -0.05 mm). The adjusted mean macular thickness change was 0.664 µm (95% CI, 0.468 to 0.859 µm) in RCO group, and 0.077 µm (95% CI, -0.048 to 0.203 µm) in OK group. No severe adverse events or significant corneal findings were observed.

Conclusions: The six-month interim analysis indicates that combining RLRL therapy with OK effectively controls myopia progression in Spanish children, with no severe adverse effects. Long-term follow-up is ongoing.