Repeated Low-Level Red-Light Therapy for Myopia Control in High Myopia Children and Adolescents: A Randomized Clinical Trial.

To assess the effectiveness and safety of repeated low-level red light (RLRL), which is a newly available treatment for myopia control in children and adolescents with high myopia. Multicenter, randomized, parallel-group, single-blind clinical trial (RCT; NCT05184621). Between February 2021 and April 2022, 192 children aged 6 to 16 years were enrolled. Each child had at least one eye with myopia of cycloplegic spherical equivalent refraction (SER) at least -4.0 diopters, astigmatism of 2.0 diopters or less, anisometropia of 3.0 diopters or less, and best-corrected visual acuity of 0.2 logarithm of the minimum angle of resolution or better. Follow-up was completed by April 2023. Participants were randomly assigned at a 1:1 ratio to intervention (RLRL treatment plus single-vision spectacles) or control (single-vision spectacles) groups. The RLRL treatment was administered for 3 minutes per session, twice daily with a minimum interval of 4 hours, 7 days per week. The primary outcome and key secondary outcome were changes in axial length and cycloplegic SER measured at baseline and the 12-month follow-up visit. Participants who had at least 1 post randomization follow-up visit were analyzed for treatment efficacy. Among 192 randomized participants, 188 (97.91%) were included in the analyses (97 in the RLRL group and 95 in the control group). After 12 months, the adjusted mean change in axial length was -0.06 mm (95% confidence interval [CI]: -0.10 to -0.02 mm) and 0.34 mm (95% CI: 0.30 to 0.39 mm) in the intervention and control groups, respectively. There were 48 participants (50.3%) of the intervention group were still experiencing axial shortening more than 0.05mm at 12-month follow-up. Furthermore, the mean spherical equivalent refraction change after 12 months was 0.11 D (95% CI: 0.02 to 0.19 D) and -0.75 D (95% CI: -0.88 to -0.62 D) in the intervention and control groups, respectively. RLRL demonstrates much stronger treatment efficacy among high myopia, with 50.3% experience substantial axial shortening. RLRL provides an excellent solution for the management of high myopia progression, a significant challenge in ophthalmology practice.

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