临床研究
ENGLISH ABSTRACT
多区正向设计离焦框架眼镜与角膜塑形镜对儿童近视的延缓效果比较
李秀红
符爱存
姫娜
王卫群
吕勇
李光光
赵兵新
覃建
作者及单位信息
·
DOI: 10.3760/cma.j.cn115989-20220517-00222
Comparison of the effect of delaying progression of myopia in children with defocus incorporated multiple segments spectacle lenses and orthokeratology
Li Xiuhong
Fu Aicun
Ji Na
Wang Weiqun
Lyu Yong
Li Guangguang
Zhao Bingxin
Qin Jian
Authors Info & Affiliations
Li Xiuhong
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
Fu Aicun
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
Ji Na
The Affiliated Eye Hospital of Suzhou Vocational Health College, Suzhou 215000, China
Wang Weiqun
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
Lyu Yong
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
Li Guangguang
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
Zhao Bingxin
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
Qin Jian
Department of Ophthalmology, Henan Eye Hospital, Henan Provincial People's Hospital, Zhengzhou 450003, China
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DOI: 10.3760/cma.j.cn115989-20220517-00222
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摘要

目的比较配戴多区正向设计离焦(DIMS)框架眼镜和角膜塑形镜对儿童近视进展的延缓效果。

方法采用非随机对照临床研究方法,纳入2018年1月至2020年12月于郑州大学第一附属医院就诊的近视儿童390例390眼,等效球镜度(SER)为-0.75~-6.00 D。依据患儿及其监护人意愿将受试者分为DIMS框架眼镜组、角膜塑形镜组和单光框架眼镜组,每组130例130眼,分别给予配戴DIMS框架眼镜、标准型或带散光设计角膜塑形镜及非球面设计的普通单光足矫框架眼镜,分别在戴镜前及戴镜后1年采用全自动电脑验光仪联合主觉验光测定受试眼SER;采用IOLMaster测量眼轴长度(AL)。最终符合纳入及排除标准的随访者共327例327眼,其中DIMS框架眼镜组107例107眼、角膜塑形镜组112例112眼、单光框架眼镜组104例104眼,均取右眼数据纳入分析。比较3个组受试眼戴镜前及戴镜后1年SER和AL及其变化量。DIMS框架眼镜组受试眼AL和SER变化量与基线资料的关系评估采用Pearson线性相关分析。

结果DIMS框架眼镜组、角膜塑形镜组、单光框架眼镜组不同时间点SER和AL总体比较差异均有统计学意义(SER: F 组别=7.065, P=0.009; F 时间=183.730, P<0.001.AL: F 组别=6.151, P=0.014; F 时间=175.290, P<0.001),戴镜后1年3个组受试眼SER和AL变化量总体比较差异均有统计学意义( F=7.065, P=0.009; F=6.151, P=0.014),其中各组1年后SER和AL均大于基线时,角膜塑形镜组和DIMS框架眼镜组SER和AL及其变化量均明显小于单光框架眼镜组,DIMS框架眼镜组SER和AL及其变化量均大于角膜塑形镜组,差异均有统计学意义(均 P<0.05)。与单光框架眼镜相比,配戴角膜塑形镜1年能分别抑制SER和AL进展58.3%和59.0%,配戴DIMS框架眼镜1年能分别抑制SER和AL进展46.9%和43.6%。戴镜1年单光框架眼镜组、角膜塑形镜组和DIMS框架眼镜组SER无变化的眼数占比分别为5.77%(6/104)、24.11%(27/112)和17.76%(19/107),AL无变化的眼数占比分别为0.00%(0/104)、8.93%(10/112)和7.48%(8/107),总体比较差异均有统计学意义( χ 2=9.316、8.676,均 P<0.001)。DIMS框架眼镜组AL变化量与年龄呈弱负相关( r=-0.252, P=0.006)。

结论配戴DIMS框架眼镜对儿童近视的延缓效果不及角膜塑形镜,但明显优于配戴普通单光框架眼镜。

近视;儿童;眼轴长度;离焦框架眼镜;角膜塑形镜;等效球镜度;视网膜离焦
ABSTRACT

ObjectiveTo compare the effect of delaying progression of myopia in children between defocus incorporated multiple segments (DIMS) spectacle lens and orthokeratology.

MethodsA nonrandomized controlled clinical study was conducted.A total of 390 children (390 eyes) with myopia who were treated in the First Affiliated Hospital of Zhengzhou University from January 2018 to December 2020 were included, with the spherical equivalent (SER) of -0.75 to -6.00 D. According to the willingness of patients and patients' guardians, the subjects were divided into DIMS group, orthokeratology group and single-vision spectacle lens group, with 130 cases (130 eyes) in each group, wearing DIMS spectacle lenses, standard or astigmatic design orthokeratology and conventional single-vision full-correction aspheric spectacle lenses, respectively.The SER of the eyes was measured using an automatic computerized refractometer in combination with subjective refraction before and one year after lens wear, and the axial length (AL) of the eyes was measured using IOLMaster.A total of 327 patients in the three groups met the inclusion and exclusion criteria, including 107 in the DIMS group, 112 in the orthokeratology group, and 104 in the single-vision spectacle lens group.All the right eyes were included in this study.The changes in SER and AL before and after wearing lenses for 1 year were compared among the three groups.The relationship between AL and SER changes and baseline data in the DIMS group was evaluated by Pearson linear correlation analysis.The study followed the Declaration of Helsinki, and the study protocol was reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Zhengzhou University (No.2023-KY-0174-002). The subjects and their guardians were fully aware of the purpose and methodology of the study, and voluntarily signed an informed consent form.

ResultsThere were statistically significant overall differences in SER and AL at different time points among the three groups (SER: F group=7.065, P=0.009; F time=183.730, P<0.001.AL: F group=6.151, P=0.014; F time=175.290, P<0.001). One year later, the differences in SER and AL changes among the three groups were statistically significant ( F=7.065, P=0.009; F=6.151, P=0.014). The SER and AL of each group after 1 year was greater than the baseline, with the SER and AL and their changes significantly smaller in orthokeratology group and DIMS group than in single-vision spectacle lens group and greater in DIMS group than in orthokeratology group, showing statistically significant differences (all at P<0.05). Compared with single-vision spectacle lenses, wearing orthokeratology for 1 year can inhibit SER and AL progression by 58.3% and 59.0%, and wearing DIMS frame glasses for 1 year can inhibit SER and AL progression by 46.9% and 43.6%.The percentage of eyes with no change in SER was 5.77%(6/104), 24.11%(27/112) and 17.76%(19/107) in the single-vision spectacle lens group, orthokeratology group and DIMS group, respectively, and the percentage of AL was 0.00%(0/104), 8.93%(10/112) and 7.48%(8/107), respectively, showing statistically significant differences among the three groups ( χ 2=9.316, 8.676; both at P<0.001). The AL change in the DIMS group was weakly negatively correlated with age ( r=-0.252, P=0.006).

ConclusionsWearing DIMS spectacle lenses is not as effective as orthokeratology in delaying myopia in children, but it is significantly better than wearing conventional single-vision spectacle lenses.

Myopia;Childhood;Axial length, eye;Defocus spectacle lenses;Orthokeratology;Spherical equivalent refraction;Retinal defocus
Wang Weiqun, Email: mocdef.6ab21983gnawix
引用本文

李秀红,符爱存,姫娜,等. 多区正向设计离焦框架眼镜与角膜塑形镜对儿童近视的延缓效果比较[J]. 中华实验眼科杂志,2024,42(04):339-346.

DOI:10.3760/cma.j.cn115989-20220517-00222

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视网膜离焦理论认为视网膜中周边的远视性离焦会导致眼轴增长及近视进展,而中周边的近视性离焦会抑制眼轴增长和近视进展 [ 1 , 2 ]。角膜塑形镜设计有基弧区和反转弧区。基弧区位于镜片的中央区,其屈光力值比角膜中央本身的屈光力值小,又称压平区,能暂时压平中央区角膜,从而提供清晰远视力;紧邻中央基弧区的旁周边区为向上拱起的反转弧区,可被泪液镜填充,相当于在基弧区周围戴了一圈会聚光线的凸透镜,而这圈凸透镜的成像区正对应于视网膜的中周边,故配戴角膜塑形镜能很好地改善视网膜中周边的远视性离焦或使其变成近视性离焦 [ 3 , 4 ],从而抑制眼轴增长及近视进展。但由于角膜塑形镜配戴相对麻烦、费时,对配戴者的卫生条件要求较高,且长期配戴有引起各种眼表疾病的风险,因此很多患儿及其监护人会选择对眼部影响小且操作相对简便的框架眼镜 [ 5 ]。离焦框架眼镜是根据角膜塑形镜的作用机制设计制作成的框架眼镜,配戴时克服了角膜塑形镜摘戴的不便。最早期设计简单的离焦框架眼镜用于临床已有10年,由于操作简便、安全性高,易被近视儿童接受,但其对儿童青少年近视的延缓效果以及其与角膜塑形镜延缓近视进展效果的比较结果目前鲜有报道。多区正向设计离焦(defocus incorporated multiple segments,DIMS)框架眼镜是近年来用于临床的改良版离焦框架眼镜,对DIMS框架眼镜的相关研究表明,DIMS框架眼镜能有效延缓儿童的近视进展及眼轴增长 [ 5 , 6 , 7 ],但这些研究中对照组受试者均为普通单光框架眼镜配戴者。本研究拟比较DIMS框架眼镜和角膜塑形镜对儿童近视的延缓效果。
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备注信息
A
王卫群,Email: mocdef.6ab21983gnawix
B

李秀红:参与试验设计、试验操作、采集/分析数据、统计分析、论文撰写及修改;符爱存、吕勇、李光光、赵兵新:参与试验操作、数据采集、论文撰写;姫娜、覃建:参与数据采集、统计分析、论文撰写及修改;王卫群:参与试验设计、研究指导、对文章知识性内容作批评性审阅及定稿

C
中国临床试验注册中心,ChiCTR2000034760
D
Chinese Clinical Trail Registry,ChiCTR2000034760
E
所有作者均声明不存在利益冲突
F
河南省教育厅高等学校重点科研项目 (23A320011)
河南省科技厅重点研发与推广专项 (201801591)
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