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非对称近视周边离焦镜片对西班牙儿童的疗效:24个月随机临床试验结果

Efficacy of Asymmetric Myopic Peripheral Defocus Lenses in Spanish Children: 24-Month Randomized Clinical Trial Results.

作者信息

Martinez-Perez Clara, Sánchez-Tena Miguel Ángel, Cleva Jose Miguel, Villa-Collar Cesar, Álvarez Marta, Chamorro Eva, Alvarez-Peregrina Cristina

机构信息

School of Management, Engineering and Aeronautics, ISEC LISBOA-Instituto Superior de Educação e Ciências, Alameda das Linhas de Torres, 179, 1750-142 Lisbon, Portugal.

Department of Optometry and Vision, Faculty of Optics and Optometry, Universidad Complutense de Madrid, 28037 Madrid, Spain.

出版信息

Children (Basel). 2025 Feb 6;12(2):191. doi: 10.3390/children12020191.

Abstract

: Asymmetric myopic peripheral defocus lenses (MPDLs) have proven to be effective in slowing the progression of myopia in Spanish children over a period of 12 months. The purpose of this study was to assess the MPDL spectacles' efficacy in slowing myopia progression over a 24-month period in children. : This study extends the follow-up period of the double-masked, prospective, and randomized clinical trial previously published to 24 months. Children from 6 to 12 years were assigned to two groups: a control group wearing spherotorical single vision lenses (SVLs) or a treatment group wearing MPDL lenses. Inclusion criteria included children with myopia less than -0.50 D, astigmatism below 1.50 D, and best-corrected visual acuity of at least 20/20. Participants underwent cycloplegic autorefractive examination and axial length (AL) measurements at the baseline and six and twelve months in the study already published, and twenty-four months later in the present study. Lifestyle factors, including outdoor activities and digital device use, were also assessed. Baseline characteristics, including age, refractive error, and AL, were comparable between groups. Dropout rates were 15.9%, with 14 participants lost to follow-up, distributed equally between the two groups. : After 24 months of follow-up, 69 children remained in this study, comprising 34 participants in the SVL cohort and 35 in the MPDL cohort. Over 24 months, the MPDL group showed significantly less AL elongation than the SVL group (0.27 ± 0.23 mm and 0.37 ± 0.24 mm; = 0.0341). The mean relative AL increase was 1.10 ± 0.95% in the MPDL group, compared to 1.56 ± 1.02% in the SVL group ( = 0.0322). Younger children exhibited faster AL growth, while digital device use and outdoor activities did not affect AL changes. : MPDL spectacle lenses substantially slowed myopia progression over a 24-month period, with 28.7% less progression in absolute AL growth and 29.8% in relative AL growth compared to SVL. These results indicate that MPDL lenses are an effective method for slowing myopia progression.

摘要

非对称近视周边离焦镜片(MPDLs)已被证明在12个月的时间里对减缓西班牙儿童近视进展有效。本研究的目的是评估MPDL眼镜在减缓儿童24个月近视进展方面的疗效。

本研究将先前发表的双盲、前瞻性、随机临床试验的随访期延长至24个月。6至12岁的儿童被分为两组:佩戴球柱面单光镜片(SVLs)的对照组或佩戴MPDL镜片的治疗组。纳入标准包括近视度数小于-0.50D、散光低于1.50D且最佳矫正视力至少为20/20的儿童。在已发表的研究中的基线、6个月和12个月时,以及在本研究中的24个月后,参与者接受了睫状肌麻痹自动验光检查和眼轴长度(AL)测量。还评估了包括户外活动和数字设备使用在内的生活方式因素。两组之间的基线特征,包括年龄、屈光不正和眼轴长度,具有可比性。失访率为15.9%,有14名参与者失访,两组分布均匀。

经过24个月的随访,本研究中仍有69名儿童,其中SVL队列中有34名参与者,MPDL队列中有35名。在24个月期间,MPDL组的眼轴伸长明显少于SVL组(分别为0.27±0.23mm和0.37±0.24mm;P = 0.0341)。MPDL组的平均相对眼轴增加为1.10±0.95%,而SVL组为1.56±1.02%(P = 0.0322)。年龄较小的儿童眼轴生长较快,而数字设备使用和户外活动并未影响眼轴变化。

MPDL眼镜镜片在24个月期间显著减缓了近视进展,与SVL相比,绝对眼轴生长进展减少了28.7%,相对眼轴生长进展减少了29.8%。这些结果表明,MPDL镜片是减缓近视进展的有效方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad6e/11854278/c5a9df14a24f/children-12-00191-g001.jpg

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