摘要
目的为了给有晶体眼后房屈光晶体(Posterior Chamber Phakic Refractive Len,PC-PRL)作医疗器械注册的临床使用评估提供科学依据。方法采用Meta分析的方法,从PubMed、万方数据库、中国知网数据库检索2000-2015年公开发表的有关A公司生产的PC-PRL的临床应用资料,分析裸眼视力(Uncorrected Visual Acuity,UCVA)、最佳矫正视力(Best Corrected Visual Acuity,BCVA)、等效球镜度数等有效性指标,以及眼压、角膜内皮细胞计数、前房深度、拱高等安全性指标。结果用STATA软件对检索到的8篇文献进行分析,发现使用PC-PRL后,UCVA提高了0.56,BCVA提高了0.07,等效球镜度数提高了12.97,说明PC-PRL可有效提高视力;同时,分析发现使用PC-PRL后,眼压无变化,细胞计数减少,前房深度减少,拱高出现,表明PC-PRL具有安全性。结论以上结果表明A公司生产的PC-PRL是一种安全有效的医用材料。
Objective To provide scientific basis for evaluation of clinical use of posterior chamber phakic refractive len(PC-PRL)for registration of medical devices.Methods Meta analysis was used to retrieve the clinical application data of PC-PRL produced by Company A published from 2000 to 2015 from PubMed,Wanfang database and CnKI database.Several effective indexes including UCVA(Uncorrected Visual Acuity),BCVA(Best Corrected Visual Acuity),the degree of equivalent ball mirror,as well as several indexes including iOP,count of corneal endothelium,anterior chamber depth,and arch height were analyzed.Results The 8 literatures were analyzed with STATA software,and UCVA and BCVA improved by 0.56,0.07 and 12.97 respectively after PC-PRL was used,indicating that PC-PRL can effectively improve vision.At the same time,the analysis found that after using PC-PRL,there was no change in iOP,cell count decreased,anterior chamber depth decreased,and arch height appeared,indicating that PC-PRL was safe.Conclusion The above results indicate that PC-PRL produced by company A is a safe and effective medical material.
作者
李敏
包家立
朱朝阳
LI Min;BAO Jiali;ZHU Chaoyang(Institute of Medical Information Technology,College of Medical Technology,Zhejiang Chinese Medical University,Hangzhou Zhejiang 310053,China;Research Team of Biophysics and Medical Engineering,Zhejiang Provincial Key Laboratory of Bioelectromagnetics,School of Medicine,Zhejiang University,Hangzhou Zhejiang 310058,China)
出处
《中国医疗设备》
2020年第7期11-14,44,共5页
China Medical Devices
基金
传染病防治国家科技重大专项课题(2018ZX10301201-002)。
