A randomized clinical trial of photobiomodulation therapy combined with continuous microlens radial array lenses for myopia control in children

Purpose To assess the clinical efficacy and safety of photobiomodulation therapy (PBMT) combined with continuous microlens radial array (CMRA) lenses in controlling myopia progression. Methods This study was designed as a prospective, randomized, double-blind, controlled clinical trial. We enrolled a total of 220 myopia aged 6–13 years. Participants were randomly assigned in a 1:1:1:1 ratio to one of four groups: Group PBMT + CMRA, Group PBMT + single vision spectacles (SVS), Group CMRA, and a control group with SVS. The primary outcomes were cycloplegic refraction and axial length (AL), measured at baseline and 6-month follow-up, using a PBMT device with a 650 nm low-intensity laser diode (0.20 mW irradiance). Results A total of 159 myopic children completed the 6-month study and were included in the final analysis. The mean axial length (AL) changes were − 0.02 ± 0.13 mm, -0.06 ± 0.38 mm, + 0.18 ± 0.07 mm, and + 0.26 ± 0.19 mm across the four groups, respectively, with a statistically significant intergroup difference (P < 0.001). No treatment-related adverse events were observed. Conclusions PBMT + CMRA demonstrated superior efficacy in controlling axial elongation compared to PBMT + SVS, CMRA, or SVS alone (P < 0.001). This combination therapy represents a promising non-pharmacological strategy for mitigating myopia progression in pediatric populations. Trial Registration NCT05756959, registered on 09/03/2023.