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Aims <p>To evaluate the efficacy of CARE spectacle lenses in slowing myopia progression among European children.</p> Methods <p>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.</p> Results <p>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 (<i>p</i> &lt; 0.01). For AL, 56.0% of SVL children had an elongation ≥0.20 mm compared to 21.3% with CARE (<i>p</i> &lt; 0.01).</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月29日

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  • Cristina Alvarez-Peregrina,
  • Miguel Angel Sanchez-Tena,
  • Cesar Villa-Collar,
  • Clara Martinez-Perez,
  • Beatriz de Corcuera-Terrero,
  • Nicole Liu,
  • Wayne Li,
  • Padmaja Sankaridurg,
  • Arne Ohlendorf,
  • Alejandro Montero Torrejon,
  • Alfredo Lopez Muñoz,
  • Alicia Ruiz Hernandez,
  • Ana Isabel Gonzalez Abad,
  • Antonio Manuel Santos de Melo,
  • Carolina Mataix Palao,
  • Christina Boeck-Maier,
  • Diego Asensio Celdrán Vivancos,
  • Isabel Rodriguez,
  • Javier Vega Dominguez,
  • João Manuel Martinho Antunes,
  • Jose Carlos Garay Dominguez,
  • Jose Ignacio Recalde Zurita,
  • Juan Luis Reina Gallego,
  • Manuel Lérida,
  • Mariano Gonzalez Perez,
  • Patricia Silva Carrola,
  • Paula Alves Silva,
  • Ramon Gutierrez Ortega,
  • Raquel Blanco Cotovio,
  • Raul Manuel Maia,
  • Siegfried Wahl,
  • Timo Kratzer,
  • Vladimiro Oliveira Hipólito

摘要

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.