[1]宋旭东,张红,叶剑,等.国产预装式人工晶状体系统安全性和有效性的多中心研究[J].眼科新进展,2020,40(3):251-256.[doi:10.13389/j.cnki.rao.2020.0059]
　SONG Xudong,ZHANG Hong,YE Jian,et al.Multi-center study on safety and efficacy of Chinese preloaded intraocular lens system[J].Recent Advances in Ophthalmology,2020,40(3):251-256.[doi:10.13389/j.cnki.rao.2020.0059]
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国产预装式人工晶状体系统安全性和有效性的多中心研究/HTML
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《眼科新进展》[ISSN:1003-5141/CN:41-1105/R]

卷:
40卷
期数:
2020年3期
页码:
251-256
栏目:
应用研究
出版日期:
2020-03-05

文章信息/Info

Title:
Multi-center study on safety and efficacy of Chinese preloaded intraocular lens system
作者:
宋旭东; 张红; 叶剑; 卢奕; 沈晔; 管怀进; 戴虹; 严宏; 陈松; 王宁利
100730　北京市，首都医科大学附属北京同仁医院，北京同仁眼科中心，北京市眼科研究所，北京市眼科学与视觉科学重点实验室（宋旭东，王宁利）；300384　天津市，天津医科大学眼科医院（张红）；400042　重庆市，陆军军医大学，陆军特色医学中心（大坪医院）（叶剑）；200031　上海市，复旦大学附属眼耳鼻喉科医院（卢奕）；310003　浙江省杭州市，浙江大学医学院附属第一医院（沈晔）；226001　江苏省南通市，南通大学附属医院（管怀进）；100730　北京市，北京医院（戴虹）；710004　陕西省西安市，西安市第四医院，陕西省眼科医院（严宏）；300052　天津市，天津医科大学总医院（陈松）
Author(s):
SONG Xudong1; ZHANG Hong2; YE Jian3; LU Yi4; SHEN Ye5; GUAN Huaijin6; DAI Hong7; YAN Hong8; CHEN Song9; WANG Ningli1
1.Beijing Tongren Hospital,Capital Medical University,Beijing Tongren Eye Center,Beijing Institute of Ophthalmology 2.Tianjin Medical University Eye Hospital 3.Army Medical Center of PLA,Army Characteristic Medical Center 4.Eye&ENT Hospital of Fudan University 5.First Affiliated Hospital,College of Medicine,Zhejiang University 6.Affiliated Hospital of Nantong University 7.Beijing Hospital 8.Xi’an Fourth Hospital,Shaanxi Eye Hospital 9.Tianjin Medical University General Hospital
关键词:
预装式人工晶状体系统; 视力; 屈光度数; 对比敏感度
Keywords:
preloaded intraocular lens system;  visual acuity;  diopter;  contrast sensitivity
分类号:
R776.1
DOI:
10.13389/j.cnki.rao.2020.0059
文献标志码:
A
摘要:
目的　通过对白内障患者术后视觉质量和并发症的临床随访，评价国产AQBHL型预装式人工晶状体（intraocular lens,IOL）系统治疗白内障的有效性和安全性。方法　多中心、随机、开放、阳性产品、平行对照临床试验。120例（120眼）受试者随机分为试验组（61例）和对照组（59例），试验组采用国产全预装系统（型号：AQBHL）植入IOL（型号：AQBH），对照组采用传统植入器和导入头植入IOL（型号：A1-UV）。术后1 d、1周、1个月、3个月、6个月和1 a进行随访，每次随访均对患眼进行视力、等效球镜度数、眼压、裂隙灯检查；术后3个月、6个月进行对比敏感度检查；术后1 a进行眼底检查和角膜内皮检查。结果　术后各随访时间点，两组受试者裸眼远视力、裸眼近视力、最佳矫正远视力、最佳矫正近视力、等效球镜度数、对比敏感度、眼压的差异均无统计学意义（均为P>0.05）；两组受试者的视力、屈光度数均在术后1个月达到稳定状态；术后各随访时间点两组受试者的视力相对术前均有显著提高（均为P<0.01）；两组手术推注过程均顺畅，均未发生术中并发症；术后早期的炎性反应，组间比较差异无统计学意义（P>0.05）；术后1 a，两组受试者角膜内皮细胞计数和角膜内皮多形性变化比较差异均无统计学意义（均为P>0.05）；随访期间未发现IOL变色、混浊、钙化等异常情况，无一例受试者进行二次手术。结论　国产AQBHL型预装式IOL系统可提供安全、可靠、可控的IOL植入过程，临床应用的安全性与非预装式推注系统相当；AQBH型IOL与A1-UV型IOL均可有效矫正白内障患者术后视力，矫正效果稳定，视觉质量优秀，生物相容性良好，术后并发症少，临床应用的有效性和安全性较高，可作为治疗白内障患者的有效手段。
Abstract:
Objective　To evaluate the efficacy and safety of Chinese AQBHL preloaded intraocular lens (IOL) system through the clinical follow-up of visual quality and complications of cataract patients after operation.Methods　Multi-center, randomized, open-label, positive and parallel controlled clinical study was conducted. Totally 120 subjects (120 eyes) were randomly divided into study group (61 cases) and control group (59 cases). IOL (model: AQBH) was implanted by a Chinese fully pre-loaded system (model: AQBHL) for cases in study group, and IOL (model: A1-UV) was implanted using a conventional injector and imported head for cases in control group. Follow-up was performed 1 day, 1 week, 1 month, 3 months, 6 months and 1 year after operation. Visual acuity, spherical equivalent, intraocular pressure and slit lamp examinations were performed at each follow-up, contrast sensitivity test was performed 3 months and 6 months after operation, fundus examinations and corneal endothelium examinations were performed 1 year after operation.Results　There were no significant differences between the two groups in uncorrected distance vision, uncorrected near vision, best corrected distance vision, best corrected near vision, spherical equivalent, contrast sensitivity and intraocular pressure at each postoperative follow-up (all P>0.05). The visual acuity and diopter of both two groups reached a steady state 1 month after operation. The visual acuity at each follow-up was significantly higher than that before operation for patients in both two groups (all P<0.01). The injection procedure was smooth in both two groups, and no intraoperative complications occurred. The early postoperative inflammatory reactions showed no statistical difference between the two groups (P>0.05). At 1 year after operation, there was no significant difference in the corneal endothelial cell count and corneal endothelium polymorphism between the two groups (both P>0.05). No abnormalities such as discoloration, opacity and calcification of the intraocular lens were observed during the follow-up period. None of the subjects underwent secondary surgery.Conclusion　Chinese AQBH preloaded IOL system can provide a safe, reliable and controllable IOL implantation process, and the safety of clinical application is equivalent to that of non-preloaded injector. Both AQBH IOL and A1-UV IOL can effectively correct the postoperative vision of cataract patients, with stable correction effect, excellent visual quality, good biocompatibility, few postoperative complications, high effectiveness and safety in clinical application, and can be used as an effective method for treating cataract patients.

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更新日期/Last Update: 2020-04-13