Clinical evaluation of MyoCare in Europe (CEME) for myopia management: One‐year results.
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| Title: | Clinical evaluation of MyoCare in Europe (CEME) for myopia management: One‐year results. |
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| Authors: | Alvarez‐Peregrina, Cristina (AUTHOR), Sanchez‐Tena, Miguel Angel (AUTHOR), Villa‐Collar, Cesar (AUTHOR), Martinez‐Perez, Clara (AUTHOR), de Corcuera‐Terrero, Beatriz (AUTHOR), Liu, Nicole (AUTHOR), Li, Wayne (AUTHOR), Sankaridurg, Padmaja (AUTHOR), Ohlendorf, Arne (AUTHOR), Torrejon, Alejandro Montero (AUTHOR), Muñoz, Alfredo Lopez (AUTHOR), Hernandez, Alicia Ruiz (AUTHOR), Abad, Ana Isabel Gonzalez (AUTHOR), de Melo, Antonio Manuel Santos (AUTHOR), Palao, Carolina Mataix (AUTHOR), Boeck‐Maier, Christina (AUTHOR), Vivancos, Diego Asensio Celdrán (AUTHOR), Rodriguez, Isabel (AUTHOR), Dominguez, Javier Vega (AUTHOR), Antunes, João Manuel Martinho (AUTHOR) |
| Source: | Ophthalmic & Physiological Optics. Jun2025, Vol. 45 Issue 4, p1025-1035. 11p. |
| Subjects: | Myopia, Clinical trials, Refractive errors, Europeans, School children, Eyeglasses, Visual acuity |
| Geographic Terms: | Europe |
| Abstract: | 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. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| Abstract: | 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. [ABSTRACT FROM AUTHOR] |
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| ISSN: | 02755408 |
| DOI: | 10.1111/opo.13517 |
