Najji Rime, Bullimore Mark, Resnikoff Serge, Bron Alain M, Naudin Mathieu, Giraud Clément, Bourne Rupert, Jonas Jost B, Leveziel Nicolas
LabCom CNRS I3M, Siemens Healthineers - University of Poitiers and CHU Poitiers, Poitiers, France.
Imaging Department, CHU Poitiers, Poitiers, France.
BMJ Open Ophthalmol. 2025 Jun 26;10(1):e002142. doi: 10.1136/bmjophth-2025-002142.
To evaluate the efficacy of myopia control by spectacle lenses in a real-world study.
This is a longitudinal, retrospective, comparative, observational, real-world study of the French Myopia Cohort. Records of prescriptions for optical correction, gender and age were collected from 1500 opticians between 2020 and 2023. The study cohort consisted of myopic children aged 4 to 15 years who were assigned to three groups: two control groups wearing single vision lenses (SVL) and one intervention group wearing myopia control spectacles (MCS); either defocus incorporated multiple segments (DIMS, n=1786) or highly aspheric lenses (HAL, n=585). The first SVL group was matched to the MCS group for age, sex and initial refractive error (first matching), and the second SVL group was matched for the same criteria and myopia progression during the first 6 months of follow-up (second matching).The difference in myopia progression was calculated between SVL groups and the MCS group. DIMS and HAL were also compared for myopia progression.
A total of 2542 children (mean age of 9.5 years and mean spherical equivalent of -2.3 D at baseline) were included in each of the three groups. The mean progression rates for MCS were by +0.59 D (95% CI +0.57 to +0.62D; p<0.001) after the first matching and by +0.30 D (95% CI +0.28 to +0.32D; p<0.001) after the second matching, in comparison to the SVL groups. Children wearing HAL spectacles showed slightly less myopia progression (difference in progression = +0.14 D, 95% CI = +0.10 to +0.18, p<0.001) compared with the DIMS group.
Although there are some limitations, including its retrospective design, the lack of lifestyle and environmental data and the use of SE rather than axial length, this study showed that in a real-world setting, both DIMS and HAL spectacles demonstrated efficacy in reducing myopia progression. While a statistically significant lower myopia progression rate was observed in the HAL group, this difference was not clinically meaningful. This study also showed that DIMS and HAL reduce myopia progression among younger children aged 4 to 6 years.
在一项真实世界研究中评估框架眼镜控制近视的疗效。
这是一项针对法国近视队列的纵向、回顾性、比较性、观察性真实世界研究。收集了2020年至2023年间1500名验光师的验光矫正处方记录、性别和年龄。研究队列包括4至15岁的近视儿童，分为三组：两个对照组佩戴单焦点镜片（SVL），一个干预组佩戴近视控制眼镜（MCS）；分别为离焦整合多焦点镜片（DIMS，n = 1786）或高非球面镜片（HAL，n = 585）。第一个SVL组在年龄、性别和初始屈光不正方面与MCS组匹配（第一次匹配），第二个SVL组在相同标准以及随访前6个月的近视进展方面进行匹配（第二次匹配）。计算SVL组和MCS组之间的近视进展差异。还比较了DIMS和HAL的近视进展情况。
三组中每组均纳入了2542名儿童（基线时平均年龄9.5岁，平均等效球镜度数为-2.3D）。与SVL组相比，第一次匹配后MCS组的平均进展率为+0.59D（95%CI +0.57至+0.62D；p<0.001），第二次匹配后为+0.30D（95%CI +0.28至+0.32D；p<0.001）。与DIMS组相比，佩戴HAL眼镜的儿童近视进展略少（进展差异 = +0.14D，95%CI = +0.10至+0.18，p<0.001）。
尽管存在一些局限性，包括其回顾性设计、缺乏生活方式和环境数据以及使用等效球镜度数而非眼轴长度，但本研究表明，在真实世界环境中，DIMS和HAL眼镜在降低近视进展方面均显示出疗效。虽然HAL组的近视进展率在统计学上显著较低，但这种差异在临床上并无意义。本研究还表明，DIMS和HAL可降低4至6岁年幼儿童的近视进展。
