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

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.