Abstract / Summary
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.