Efficacy and Safety of Dual-Sided Composite Defocus Spectacles for Myopia Control in Children: A 1-Year Randomized, Double-Masked, Controlled Trial.

Abstract

To investigate the efficacy and safety of a novel dual-sided composite defocus (DSCD) lens for pediatric myopia control. Prospective, randomized, double-masked, three-arm, parallel-controlled clinical trial with 1-year follow-up. A total of 225 children aged 6-14 years with myopia ranging from -0.50 D to -6.00 D were randomized 1:1:1 to DSCD, single-surface defocus (SSD), or single-vision spectacle (SVS) lenses. Overall, 194 participants (86.2%) completed the 1-year follow-up. Participants were randomly assigned to the DSCD, SSD, or SVS lens group. The DSCD lens incorporated a front-surface microlens array and a posterior freeform aspheric design intended to generate an asymmetric peripheral myopic defocus profile. Outcomes were measured at baseline and during the 12-month follow-up. Statistical analyses included analysis of covariance, Pearson correlation, and exploratory subgroup analyses. The primary outcomes were 12-month changes in axial length (AL) and spherical equivalent refraction (SER). At 12 months, the DSCD group exhibited significantly less SER progression than the SVS group (-0.22 ± 0.37 D vs -0.83 ± 0.47 D; P < 0.001) and the SSD group (-0.22 ± 0.37 D vs -0.45 ± 0.43 D; P = 0.005). Axial elongation was also significantly slower with DSCD than with SVS lenses (0.19 ± 0.14 mm vs 0.42 ± 0.18 mm; P < 0.001). No statistically significant difference in axial elongation was observed between the DSCD and SSD groups. The DSCD lens reduced SER progression by 73.6% and AL elongation by 55.2% relative to SVS lenses. Exploratory subgroup analyses suggested less progression in children aged 8-12 years, those with baseline AL of 24-25 mm, and those with low myopia. No lens-related adverse events were observed, and all groups demonstrated high compliance and good adaptation. Over 12 months, DSCD lenses resulted in significantly less SER progression and axial elongation than SVS lenses. Compared with the SSD lenses tested in this study, DSCD lenses showed significantly less SER progression, whereas the difference in axial elongation was not statistically significant. DSCD lenses were generally well tolerated and may represent a spectacle-based option for pediatric myopia control.