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

IF 2.8 3区 医学 Q1 OPHTHALMOLOGY
Ophthalmic and Physiological Optics Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI:10.1111/opo.13517
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
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引用次数: 0

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.

欧洲心肌治疗近视的临床评价:一年的结果。
目的:评价CARE眼镜镜片在减缓欧洲儿童近视进展中的疗效。方法:在一项为期2年的随机、平行组、双盲、多中心临床试验中,招募了234名6-13岁的欧洲儿童。所有受试者均为近视,前一年近视度数≥0.50 D,散光≤1.50 D,屈光参差≤1.00 D,近视度数≥0.50 D。治疗组采用带圆柱形环形屈光元件(CARE)的心肌镜片,对照组采用单视力镜片(SVL)。在基线、6个月和12个月测量轴长(AL)和SE。可穿戴性问卷分别于1周和3个月进行。分别记录配药时和3个月后的中央和周围视力(VA)。广义线性模型估计了SE和AL的变化,调整了晶状体类型、年龄和基线测量。结果:12个月后,佩戴CARE镜片的儿童近视进展较少,SE和AL进展差异(与SVL相比)分别为-0.21 D (CI: 0.10至0.32 D)和0.14 mm (CI: -0.17至-0.10 mm)。使用CARE隐形眼镜时,中央VA没有下降。外周VA在鼻区和颞区分别下降0.10和0.09 logMAR。快速进展分析表明,39.7%的SVL配戴者的近视进展速度≤-0.50 D/年,而CARE配戴者为21.1% (p)。结论:在欧洲儿童中,与SVL配戴1年后相比,CARE配戴者的近视进展速度明显慢于SVL。进一步的监测将提供长期疗效的综合评价。
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来源期刊
CiteScore
5.10
自引率
13.80%
发文量
135
审稿时长
6-12 weeks
期刊介绍: Ophthalmic & Physiological Optics, first published in 1925, is a leading international interdisciplinary journal that addresses basic and applied questions pertinent to contemporary research in vision science and optometry. OPO publishes original research papers, technical notes, reviews and letters and will interest researchers, educators and clinicians concerned with the development, use and restoration of vision.
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