Abstract
Purpose :
Orthokeratology (Ortho-k) is currently the only solution that achieves “glasses-off” vision (free from spectacles and contact lenses) during the daytime, and repeated low-level red-light (RLRL) therapy has demonstrated strong efficacy in controlling myopia progression. This study aims to investigate the efficacy and safety of combining these two solutions among school-aged children.
Methods :
In this multicenter, randomized, parallel-group, single-blind clinical trial, children aged 8-13 years with a cycloplegic spherical equivalent refraction of -1.00 to -5.00 diopters (D), astigmatism of 1.50 D or less, and anisometropia of 1.50 D or less in the initial Ortho-k fitting examination, and who had poorly controlled myopia despite using Ortho-k for 1 year (annual axial length [AL] elongation ≥ 0.50 mm), were randomly assigned to the RLRL combined with Ortho-k (RCO) group or the Ortho-k group in a 2:1 ratio. The Ortho-k group wore Ortho-k lenses at night for at least 8 hours per day only, while the RCO group additionally received daily RLRL therapy twice a day for 3 minutes, with sessions spaced at least 4 hours apart. The primary outcome was the change in AL measured at 12 months relative to baseline, based on the modified intention-to-treat principle (ClinicalTrials.gov, NCT04722874).
Results :
A total of 47 (97.9%) children were included in the analysis (30 in the RCO group and 17 in the Ortho-k group). The mean axial elongation rate before the trial was 0.597 mm/year in the RCO group and 0.612 mm/year in the Ortho-k group. After 12 months following the intended intervention, the adjusted mean AL changes were -0.024 mm (95% CI: -0.078 to 0.030 mm) in the RCO group and 0.265 mm (0.191-0.338 mm) in the Ortho-k group. The adjusted mean difference in AL changes was 0.288 mm (0.137-0.440 mm) between the RCO and Ortho-k groups. No serious adverse events, ocular damage, or increased incidence of contact lens-related adverse events were observed following RLRL therapy.
Conclusions :
Combined therapy with RLRL and Ortho-k is likely to offer the advantages of “glasses-off” vision during daytime and full control of myopia progression.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.