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角膜塑形镜配戴矫治高度近视的回顾性队列研究

A retrospective cohort study on orthokeratology for high myopia progression

摘要目的 探讨角膜塑形镜矫正青少年高度近视的临床疗效和安全性. 方法 采用回顾性队列研究方法,对2013年6月至2014年6月在河南省立眼科医院配戴角膜塑形镜并按要求复查12个月且资料完整的青少年高度近视患者60例120眼临床资料进行分析,选择同期配戴单焦点框架眼镜并按要求随访12个月的青少年高度近视患者59例118眼临床资料作为对照.所有患者等效屈光度(SE)为-6.00 ~9.00 D,2个组间患者和患眼基线特征均匹配.角膜塑形镜组患者按照国家食品药物监督管理局(CFDA)的规定将角膜塑形镜最大矫正幅度设定为6.00D,首次配戴角膜塑形镜1个月后残余的近视度数则通过白天配戴框架眼镜、夜戴角膜塑形镜的方法进一步矫正,框架眼镜组患者仅配戴框架眼镜.分别于戴镜后1周及1、3、6和12个月复查矫正眼裸眼视力(UCVA)、屈光度、角膜荧光素染色等,于戴镜后6个月、12个月行眼轴长度和角膜内皮细胞检查.结果 角膜塑形镜组患者戴镜后随着时间延长SE逐渐下降,UCVA逐渐增加,而框架眼镜组患者矫正后随着时间延长SE和UCVA均无明显变化.角膜塑形镜组患者戴镜后1周UCVA明显提高,SE明显下降,戴镜后1、3、6和12个月患者UCVA明显高于戴镜后1周,SE明显低于戴镜后1周,差异均有统计学意义(均P<0.01),而框架眼镜组患者戴镜后各时间点UCVA变化的差异均无统计学意义(均P>0.05),戴镜后12个月SE较戴镜前明显提高,差异有统计学意义(P<0.01).角膜塑形镜组患者戴镜后各时间点SE均明显低于框架眼镜组,差异均有统计学意义(均P<0.01).戴镜后12个月,框架眼镜组眼轴增长度为(0.29±0.14)mm,明显长于角膜塑形镜组的(0.08±0.12) mm;框架眼镜组SE增长(0.69±0.27)D,明显高于角膜塑形镜组的(0.19±0.21)D,差异均有统计学意义(t=10.024、5.691,均P<0.01).2个组间患者戴镜后6个月及12个月的角膜内皮细胞密度、六角形细胞百分率及变异系数总体比较差异均无统计学意义(角膜内皮细胞密度:F分组=0.090,P=0.769;F时间=0.133,P=0.563.六角形细胞百分率:F分组=0.071,P=0.836;F时同=1.091,P=0.203.变异系数:F分组=0.107,P=0.734;F时间=1.948,P=0.156).角膜塑形镜组患者戴镜期间角膜点染率为31.67%,明显高于框架眼镜组的3.51%,差异有统计学意义(x2=97.910,P=0.001). 结论 与配戴框架眼镜相比,配戴角膜塑形镜配戴可更好地改善青少年高度近视患者UCVA和控制眼轴的增长,但更易发生角膜浅层组织的损伤.

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abstractsObjective To study the therapeutic effect and safety of orthokeratology in the teenagers with high myopia.Methods A retrospective cohort study was carried out.The clinical data of 120 eyes from 60 high myopia patients wearing orthokeratology contact lens for 1 year in Henan Eye Hospital from June 2013 to June 2014 was analyzed,and the data of contemporaneous 118 eyes from 59 matched high myopia patients wearing conventional glasses were used as controls.The initial spherical equivalent (SE) of all the patients was-6.00 to-9.00 D.The maximum correction amplitude of the orthokeratology contact lens was set as 6.00 D based on the Regulation of China Food & Drug Administration.The contact lenses were worn for 1 month firstly and then the conventional glasses were used at daytime and contact lenses were consecutively worn at night for 1 year in the contact lenses group,and only glasses were worn in the conventional glasses group.The uncorrective visual acuity (UCVA),SE,corneal fluorescein staining were examined 1 week,1 month,3 months,6 months and 12 months after wearing lenses.The changes of corneal endothelial cells were examined 6 and 12 months after wearing lenses.Results The UCVA was improved and SE was reduced 1 month and 3,6 and 12 months after wearing lenses in comparison with 1 week after wearing lenses in the contact lenses group (all at P<0.01);while no significant change was seen in UCVA in the conventional glasses group (all at P>0.05).Compared with wearing contact lenses,the SE was increased in various time points after wearing glasses in the conventional glasses group (all at P<0.01).The axial length and SE extended by (0.08±0.12)mm and (0.19±0.21)D in the contact lenses group and those in the conventional glasses group were (0.29±0.14)mm and (0.69±0.27)D,showing significant differences between the two groups (t =10.024,5.691,both at P<0.01).No significant differences were found in corneal endothelial cell density,percentage of hexagonal cells and coefficient of variation of corneal endothelial cells in various time points after wearing contact lenses (corneal endothelial cell density:Fgroup =0.090,P =0.769;Ftime =0.133,P =0.563.percentage of hexagonal cells:Fgroup =0.071,P=0.836;Ftime =1.091,P =0.203.coefficient of variation:Fgroup =0.107,P =0.734;Ftime =1.948,P =0.156).The incidence of corneal fluorescein staining was 31.67% in the contact lens group,which was much higher than 3.51% in the conventional glasses group (x2 =97.910,P =0.001).Conclusions Compared with wearing only conventional glasses,orthokeratology can improve UCVA and control axial length extension in juvenile with high myopia,but orthokeratology is more likely to damage the corneal superficial layer.

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栏目名称 临床研究
DOI 10.3760/cma.j.issn.2095-0160.2018.02.014
发布时间 2018-03-23
基金项目
河南省医学科技攻关计划项目(201503203)Henan Medical Science and Technology Project
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中华实验眼科杂志

中华实验眼科杂志

2018年36卷2期

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