Abstract
Purpose :
Two recent clinical trials have demonstrated that spectacle lenses with highly aspherical lenslets (HAL) slow myopia progression in Asian children. This extension of a clinical trial assesses the 4-year increase of myopia and axial length (AL) with HAL.
Methods :
Forty-four of 51 children who wore HAL for three years accepted to be followed for two more years. Spherical equivalent of cycloplegic autorefraction (SER) and AL were measured at the end of year 4. Change of AL with HAL was compared to a single vision lens (SVL) model based on SVL data of the first two years of the same clinical trial and an average decrease of change in AL by 15% per year (Shamp W, et al. IOVS 2022;63:ARVO E-Abstract A0111). As the change of SER and AL were highly correlated in the SVL group at second year (p<0.001, r= -0.91), the same model was applied to SER.
Results :
During the fourth year, 1 child had discontinued from the trial due to COVID restrictions in traveling. The 43 children who completed the fourth year follow-up were aged (± SD) 13.7±1.1 years (from 11 to 15) with average SER of -3.70±1.22 D and AL of 25.28±0.84 mm. In the fourth year, the control group model predicted an increase in SER(±SE) and AL(±SE) of -0.46±0.03 D and 0.23±0.01 mm, respectively, leading to a 4-year change of SER: -2.46±0.14 D and AL: 1.20±0.06 mm. For children wearing HAL, the change in SER and AL during the fourth year were -0.23±0.04 D (-0.23 D less than control, p<0.001) and 0.11±0.02 mm (0.12 mm less than control, p<0.001), respectively. Over 4 years, SER in the HAL group increased by -1.13±0.13 D while AL elongated by 0.58± 0.05 mm, i.e., 1.34 D (54%) and 0.62 mm (52%) less than in the modeled control group.
Conclusions :
Myopia progression and axial elongation in children wearing HAL was slower than in a modeled control SVL group during year 4 of this clinical trial. Myopia control efficacy with HAL is sustained in older children (11-15 y.o.) over a four-year period.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.