Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial.

Abstract

Myopia prevalence is rising in the US. Spectacle lenses with highly aspherical lenslets (HAL) are effective in Asian populations but unproven in US children. To evaluate the 24-month safety and effectiveness of HAL spectacle lenses compared with single-vision spectacle lenses (SVL) in US children with myopia. This double-masked randomized clinical trial took place at 9 investigational sites in the US and included children aged 6 to 12 years with a manifest spherical equivalent refraction (SER) of -0.75 to -4.50 diopters (D). Key exclusion criteria included a history of prior myopia control intervention, strabismus, amblyopia, or any ocular or systemic conditions and medications affecting refractive status. Enrollment was from December 2021 to July 2022, and the 24-month follow-up reported here was completed in October 2024. Participants were randomized (1:1) to HAL or SVL. Primary outcomes were 24-month changes in cycloplegic SER (cSER) and axial length. Of 159 randomized participants (80 [50.3%] male; mean [SD] age, 9.7 [1.6] years), 135 (84.9%) completed the 24-month assessment. The baseline mean (SD) cSER was -2.21 (1.07) D in the HAL group and -2.05 (1.22) D in the SVL group. At 24 months, adjusted mean (SE) myopia progression was -0.25 (0.05) D in the HAL group and -0.90 (0.05) D in the SVL group (difference, 0.64 D; 95% CI, 0.50 to 0.79; P < .001), a 71% relative reduction. The baseline mean (SD) axial length was 24.26 (0.92) mm in the HAL group and 24.32 (0.83) mm in the SVL group. Adjusted mean (SE) axial elongation was 0.21 (0.02) mm in the HAL group and 0.45 (0.02) mm in the SVL group (difference, -0.24 mm; 95% CI, -0.29 to -0.19; P < .001), a 53% relative reduction. Best-corrected visual acuity was equivalent between groups (mean difference, -0.01 logMAR; 95% CI, -0.02 to 0.00; P = .23). Ocular adverse events occurred in 9 of 77 participants the HAL group (11.7%) vs 12 of 82 in the SVL group (14.6%); none were serious or lens related. The total number of subjective symptom reports were 19 (HAL) and 25 (SVL). In this randomized clinical trial of US children, spectacle lenses with HAL provided a reduction in myopia progression and axial elongation over 24 months. While longer-term data are needed to evaluate sustained treatment efficacy, these findings support HAL as a safe and effective myopia control intervention and underlie US Food and Drug Administration authorization of the study device. ClinicalTrials.gov Identifier: NCT05174780.