Three-year results of cylindrical annular refractive elements (CARE) spectacle lenses in slowing myopia progression

Purpose To evaluate the 3-year efficacy of spectacle lenses incorporating cylindrical annular refractive elements (CARE and CARE S) in slowing myopia progression and axial elongation in children, and to assess whether treatment effects were sustained over time. Methods 240 Chinese children aged 6–13 years with myopia of -0.75 to -5.00 D were enrolled in a multicentre, prospective, parallel-group, double-masked, randomized clinical trial and randomly assigned to wear single-vision (SV), CARE, or CARE S spectacle lenses. Cycloplegic spherical equivalent refraction (SE) and axial length (AL) were measured at 6-month intervals. After completion of the 2-year trial, participants were invited to continue for an additional year. At 30 months, children in the SV group were switched to CARE lenses, and hence Year 3 SV progression was estimated using linear mixed-effects models derived from observed data over the first 2 years. Three-year outcomes were adjusted for age, sex, study site, baseline refraction, and compliance. Results A total of 186 participants (78%) completed the 3-year follow-up. Over 3 years, adjusted mean SE progression was − 1.69 D (95% CI, -1.85 to -1.53) in the SV group, compared with − 1.07 D (95% CI, -1.23 to -0.91) in the CARE group and − 1.24 D (CI, -1.40 to -1.08) in the CARE S group. Adjusted mean AL elongation was 0.85 mm (CI, 0.78 to 0.92) with SV lenses, 0.57 mm (CI, 0.50 to 0.64) with CARE lenses, and 0.67 mm (CI, 0.60 to 0.73) with CARE S lenses. Relative to SV lenses, myopia progression was reduced by 0.62 D/0.28 mm, and 0.45 D/0.18 mm with CARE and CARE S lenses respectively. Efficacy accrued with time. Comparing year to year change, annual progression with SV declined with time whereas CARE and CARE S groups demonstrated similar year to year changes. Conclusions CARE and CARE S spectacle lenses demonstrated sustained efficacy in slowing myopia progression and axial elongation over 3 years in Chinese children. Greater efficacy was observed with CARE lenses. Despite age-related slowing of progression in the control group, CARE and CARE S lenses demonstrated consistent slowing. The clinically meaningful differences in slowing of myopia with CARE-based spectacle lenses support their use as a safe and effective option for myopia management in children. Trial registration ClinicalTrials.gov, NCT05288335. Registration Date: February 9, 2022.