To evaluate over a 2-year period the efficacy of spectacle lenses incorporating cylindrical annular refractive elements (CARE) in slowing myopia progression compared with single vision (SV) spectacle wear.

Double-masked, multicenter, randomized clinical trial.

A total of 240 Chinese children aged 6 to 13 years, with a spherical equivalent (SE) refractive error of –0.75 diopters (D) to –5.00 D, were randomized to 1 of 3 groups of SV spectacle lens: CARE spectacles (7-mm central clear zone surrounded by treatment zone incorporating CARE with mean surface power +4.6 D) and CARE S spectacles (9-mm central clear zone surrounded by treatment zone comprising CARE with mean surface power +3.8 D). Cycloplegic SE and axial length (AL) were measured at 6-month intervals.

Progression (mean ± SD) in SV-wearing eyes after 24 months of SPL wear was –1.15 ± 0.63 D and 0.59 ± 0.26 mm with SV for SE and AL, respectively. In comparison, myopia progression was significantly slower with both CARE (–0.73 ± 0.63 D/0.40 ± 0.26 mm, P < .0001) and CARE S (–0.80 ± 0.56 D/0.44 ± 0.25 mm, P < .0001). Progression did not differ significantly between CARE lenses. Adjusting for site, group, age, gender, and baseline value at 24 months, CARE showed an absolute difference in SE of 0.44 D (95% CI, 0.21-0.66 D) and CARE S 0.41 D (95% CI, 0.18-0.63D) compared with SV. AL reduction was 0.20 mm (95% CI, 0.10-0.30 mm) with CARE and 0.17 mm (0.07-0.26 mm) with CARE S compared with SV.

Over a 2-year period, lenses incorporating CARE significantly slowed myopia progression compared with SV lenses.