Slowing myopia progression with cylindrical annular refractive elements (CARE) spectacle lenses-Year 1 results from a 2-year prospective, multi-centre trial.

Abstract

To evaluate the effectiveness of 12 months of spectacle lens wear incorporating cylindrical annular refractive elements (CARE) in slowing myopia progression compared to single vision (SV) spectacle wear. In an ongoing 2-year prospective, double-masked, multi-centre clinical trial, 240 Chinese children aged 6-13 years, spherical equivalent refractive error (SE) -0.75 D to -5.00 D were randomised to one of three groups of 80 participants each to wear: SV spectacle lens (N = 80), CARE spectacles (7 mm central clear zone surrounded by treatment zone incorporating CARE with mean surface power of +4.6 D) and CARE S (9 mm central clear zone surrounded by treatment zone comprising CARE with mean surface power of +3.8 D). Cycloplegic SE and axial length (AL) were measured at 6-month intervals. Compared to baseline, changes in SE and AL were significantly different between the groups at both 6 and 12 months (p < 0.001, linear mixed model). Adjusting for site, group, parental myopia and age, at 12 months, the estimated change in SE and AL with 95% CI with SV was -0.65 D (CI: -0.56 to -0.74 D)/0.32 mm (CI: 0.29-0.36 mm). In comparison, the estimated change in SE/AL at 12 months with CARE was -0.35 D (-0.26 to -0.44 D)/0.19 mm (0.15-0.22 mm) and with CARE S was -0.36 D (-0.27 to -0.46 D)/0.21 mm (0.18-0.25 mm) at 12 months. Progression was slower with CARE and CARE S compared to SV (p < 0.05) but did not differ from each other (p = 0.793 and 0.336 for SE and AL, respectively). In children with myopia, after 12 months of lens wear, both CARE and CARE S spectacle lenses significantly slowed myopia progression compared to SV lenses.