Alvarez-Peregrina Cristina, Sanchez-Tena Miguel Angel, Villa-Collar Cesar, Martinez-Perez Clara, de Corcuera-Terrero Beatriz, Liu Nicole, Li Wayne, Sankaridurg Padmaja, Ohlendorf Arne
Department of Optometry and Vision, Faculty of Optics and Optometry, Universidad Complutense de Madrid, Madrid, Spain.
ISEC LISBOA-Instituto Superior de Educação e Ciências, Lisbon, Portugal.
Ophthalmic Physiol Opt. 2025 Jun;45(4):1025-1035. doi: 10.1111/opo.13517. Epub 2025 Apr 29.
To evaluate the efficacy of CARE spectacle lenses in slowing myopia progression among European children.
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.
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).
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.
评估CARE眼镜片对减缓欧洲儿童近视进展的疗效。
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至13岁的欧洲儿童。所有参与者均为近视，其睫状肌麻痹等效球镜屈光不正（SE）在-0.75 D至-5.00 D之间，散光≤1.50 D，屈光参差≤1.00 D，且前一年近视进展至少为0.50 D。治疗组佩戴带有柱面环形屈光元件（CARE）的MyoCare眼镜片，对照组佩戴单焦点眼镜片（SVL）。在基线、6个月和12个月时测量眼轴长度（AL）和SE。在1周和3个月时进行佩戴舒适度问卷调查。在配镜时和3个月后记录中央和周边视力（VA）。采用广义线性模型估计SE和AL的变化，并对镜片类型、年龄和基线测量值进行校正。
12个月后，佩戴CARE镜片的儿童近视进展较慢，SE和AL进展（与SVL相比）的差异分别为-0.21 D（可信区间：0.10至0.32 D）和0.14 mm（可信区间：-0.17至-0.10 mm）。佩戴CARE镜片时中央视力没有下降。周边视力在鼻侧和颞侧区域分别下降了0.10和0.09 logMAR。对快速进展者的分析表明，佩戴SVL的眼睛中有39.7%的年进展≤-0.50 D，而佩戴CARE的为21.1%（p<0.01）。对于AL，佩戴SVL的儿童中有56.0%的眼轴伸长≥0.20 mm，而佩戴CARE的为21.3%（p<0.01）。
在欧洲儿童中，佩戴镜片1年后，与SVL相比，CARE镜片的近视进展明显较慢。进一步监测将对长期疗效进行全面评估。
