Six-month efficacy of red-light therapy and customised orthokeratology for myopia control in Spanish children

Aims/Purpose: To evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy with customised orthokeratology (Ortho-K) for myopia control in Spanish children.

Methods: This single-site, randomised, parallel-group, non-blinded trial enrolled 26 children aged 10-13 years with myopia. A total of 26 children were enrolled, completing the 6-month follow-up in May 2024. Children were randomly assigned to either the RLRL combined with the Ortho-K or the Ortho-K-only group. The Ortho-K group was required to wear Ortho-K lenses for at least 8 hours per night. In addition to wearing Ortho-K lenses in the adjunct therapy group, daily RLRL therapy was administered twice a day for 3 minutes per session. The primary outcome was the axial length (AL) change measured at 6 months relative to baseline.

Results: Twenty-six children completed the study (11 in the RLRL + Ortho-K group and 15 in the Ortho-K group). After 6 months, the mean AL change was -0.06 mm (95% CI, -0.12 to 0.01 mm) in the RLRL +Ortho-K group, significantly lower than in the Ortho-K group (0.04 mm [-0.12 to 0.01 mm], p = 0.001). In the RLRL + Ortho-K group, 5 children (45.5%) achieved significant axial shortening (AL changes < = -0.05 mm). The mean change in macular thickness was 0.66 μm (95% CI, 0.05 to 1.28 μm) in the RLRL + Ortho-K group, significantly greater than in the Ortho-K group (0.08 μm [0.001 to 0.15 μm], p = 0.022). No severe adverse events were reported, such as vision loss, scotoma, functional visual loss, or structural damage on OCT scans. No significant corneal findings were observed.

Conclusions: Combining RLRL therapy with customised Ortho-K shows promise for controlling myopia progression in Spanish children. This approach may provide clinical benefits in managing myopia without severe adverse effects.