Clinical evaluation of MyoCare in Europe (CEME) for myopia management: One-year results.

AIMS

To evaluate the efficacy of CARE spectacle lenses in slowing myopia progression among European children.

METHODS

In a 2-year randomised, parallel-group, double-masked, multicentre clinical trial, 234 European children aged 6-13 years were enrolled. All participants were myopic, with a cycloplegic spherical equivalent refractive error (SE) between -0.75 D and -5.00 D, astigmatism ≤1.50 D, anisometropia ≤1.00 D and myopia progression of at least 0.50 D in the previous year. The treatment group received MyoCare spectacle lenses with cylinder annular refractive elements (CARE), the control group single-vision lenses (SVL). Axial length (AL) and SE were measured at baseline, 6 and 12 months. Wearability questionnaires were administered at 1 week and 3 months. Central and peripheral visual acuity (VA) was recorded at dispensing and after 3 months. Generalised linear models estimated changes in SE and AL, adjusting for lens type, age and baseline measurements.

RESULTS

After 12 months, children wearing CARE lenses showed less myopia progression, with a difference in SE and AL progression (compared to SVL) of -0.21 D (CI: 0.10 to 0.32 D) and 0.14 mm (CI: -0.17 to -0.10 mm), respectively. Central VA did not decrease with CARE lenses. Peripheral VA decreased by 0.10 and 0.09 logMAR in the nasal and temporal zones, respectively. Analysis of fast progressors indicated that 39.7% of SVL wearing eyes progressed by ≤-0.50 D/year compared to 21.1% with CARE (p < 0.01). For AL, 56.0% of SVL children had an elongation ≥0.20 mm compared to 21.3% with CARE (p < 0.01).

CONCLUSIONS

In European children, myopia progression was significantly slower with CARE lenses compared with SVL after 1 year of lens wear. Further monitoring will provide a comprehensive evaluation of long-term efficacy.