Systemic Evaluation of the Clinical Safety and Effectiveness of the Posterior
Chamber Phakic Refractive Len
LI Min1
, BAO Jiali2
, ZHU Chaoyang2
1. Institute of Medical Information Technology, College of Medical Technology, Zhejiang Chinese Medical University, Hangzhou
Zhejiang 310053, China; 2. Research Team of Biophysics and Medical Engineering, Zhejiang Provincial Key Laboratory of
Bioelectromagnetics, School of Medicine, Zhejiang University, Hangzhou Zhejiang 310058, China
Abstract：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.
李敏1
，包家立2
，朱朝阳2. 有晶体眼后房屈光晶体临床安全性和有效性的系统评价[J]. 中国医疗设备, 2020, 35(7): 11-14.
LI Min1
, BAO Jiali2
, ZHU Chaoyang2. Systemic Evaluation of the Clinical Safety and Effectiveness of the Posterior
Chamber Phakic Refractive Len. China Medical Devices, 2020, 35(7): 11-14.
