New design peripheral defocus spectacle lens vs. single-vision for slowing myopia progression in children: randomized controlled trial

Abstract

This study reports the 1-year results of a 2-year multicenter prospective randomized, controlled, double-masked trial aimed to determine whether Myoslow lenses (Crystal Optic Industries Ltd., Acre, Israel) based on the peripheral defocus mechanism of action can slow myopia progression. Children aged 6–12 years with myopia between − 1.00 D and − 5.00 D and astigmatism ≤ 1.50 D (N = 121) received either Myoslow (treatment) or single vision (control) spectacle lenses. The mean change in spherical equivalent refractive error from baseline was − 0.46 D in the treatment group and − 0.65 D in the control group (p = 0.015), with myopia progression slowed by 0.19 D (29.5%). The mean change in axial length was 0.27 mm in the treatment group and 0.36 mm in the control group (p = 0.002), with myopia progression slowed by 0.09 mm (23.6%). Younger age was the only covariate significantly associated with the treatment effect across both outcome measures, with a significant correlation between the treatment effects in the two measures (R = − 0.71, p < 0.001). Treatment was well tolerated, with only one ocular complication: myopia progression (0.08%). Myoslow lenses effectively and safely slow myopia progression in children, with greater benefit in younger ages compared to single vision lenses.