Multipoint Defocus Optics Technology Spectacle Lenses for Myopia Control in Children: A One-Year Interim Analysis of a Randomized Trial

Abstract

Purpose To evaluate the one-year efficacy of novel partition multipoint defocus optics technology (PMDOT) lenses in slowing myopia progression, compared to lenses with highly aspherical lenslets (HAL). Methods This is a 1-year interim analysis of an ongoing 2-year, non-inferiority randomized controlled trial, in which 194 children ages 8 to 13 years with spherical equivalent refraction (SER) of −0.75 to −4.5 diopters (D) were randomized to either the PMDOT or HAL group. The primary outcome of the full trial was the mean between-group difference in SER change at 2 years, and the non-inferiority margin was −0.3 D. Secondary outcomes included changes in axial length (AL), choroidal thickness (ChT), and other biometric parameters, as well as best-corrected visual acuity (BCVA) at 2 years and subjective visual experience. Data from right eyes were used for the current analysis. Results The study included 102 children in the PMDOT group and 92 in the HAL group. After 1 year, the mean ± SD changes in SER and AL were not statistically significantly different between the two groups (PMDOT vs. HAL SER −0.74 ± 0.49 D vs. −0.60 ± 0.48 D, AL 0.26 ± 0.20 mm vs. 0.19 ± 0.19 mm) based on per-protocol (PP) analysis. The between-group difference in SER change at 12 months was −0.09 D (two-sided 97% confidence interval [CI], −0.26 to 0.09). Except for the change in anterior chamber depth in the PP analysis, no significant between-group differences were observed for any secondary outcomes. Conclusions PMDOT lenses were not inferior to HAL lenses in controlling myopia progression. Translational Relevance This trial demonstrated the clinical potential of PMDOT lenses for myopia control in schoolchildren.