ZEISS MyoCare (CARE) – Clinical Evaluation of MyoCare in Europe (CEME) Study
1. Study Design & Scope
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A prospective, multicenter, double-masked, randomized clinical trial conducted across Asia (China) and Europe.
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European cohort (CEME Study):
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Enrolled around 234–304 Caucasian children aged 6–13 years.
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Eligibility: cycloplegic spherical equivalent (SE) between –0.75 D and –5.00 D, with past annual progression of at least –0.50 D.
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Treatment group wore ZEISS MyoCare spectacle lenses with cylindrical annular refractive elements; control group wore single-vision lenses (SVL).
2. Efficacy Results: Refractive Error & Axial Length
Asian Children (2-Year Data)
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After 24 months:
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Myopia progression slowed by 0.44 D compared to SVL.
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Axial length (AL) elongation reduced by 0.20 mm.
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Variant MyoCare S:
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Slowed progression by 0.41 D and AL by 0.17 mm.
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Caucasian (European) Children (1-Year Data)
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After 12 months:
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Myopia progression slowed by 0.21 D.
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AL growth reduced by 0.14 mm.
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Significant reduction in “fast progression” cases (progression ≥ 0.50 D or AL ≥ 0.20 mm).
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ZEISS MyoCare showed consistent benefit regardless of prior progression history.
3. Tolerability & Adaptation
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Rapid adaptation observed: 84% of lens wearers adapted within 3 days in Europe.
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Visual performance ratings:
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95% rated distance vision as “good or very good”.
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93% rated near vision positively.
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96% reported good vision during sports and daily activities.
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4. Visual Acuity & Subjective Comfort
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At dispensing:
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Central visual acuity was slightly better with MyoCare than SVL (not clinically significant).
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Peripheral visual acuity was about one line lower with MyoCare.
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At 3 months:
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Central vision and subjective adaptation scores matched SVL.
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Peripheral vision reduction persisted but remained within acceptable clinical limits.
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Adaptation scores improved over time, showing equivalence to SVL by 3 months for most parameters.
Summary Table: Key Findings
Population | Duration | SE Slowdown | AL Slowdown | Fast Progression Reduced | Adaptation Rate | Visual Tolerance |
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Asian children | 24 months | 0.44 D | 0.20 mm | — | — | — |
European children | 12 months | 0.21 D | 0.14 mm | Yes | 84% within 3 days | 93–96% rated vision “good or very good” |
Visual comfort | 3 months | — | — | — | Improved, equal to SVL | Slight peripheral VA decrease (1 line) |
Why These Findings Matter
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Cross-population efficacy: ZEISS MyoCare demonstrated consistent benefits across Asian and European children, proving applicability across diverse ethnic groups.
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High compliance potential: Rapid adaptation and strong subjective satisfaction indicate high likelihood of long-term daily wear.
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Clinically acceptable trade-offs: Slight reductions in peripheral vision were observed, but overall visual acuity and comfort matched single-vision standards within a few months.
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