领扣型人工角膜治疗高危移植角膜盲的多中心临床研究  

A multicenter clinical trial of collar-button type keratoprosthesis implantation for the treatment of corneal blindness in high-risk transplantation

作　　者：张婷 王丽强[2] 顾建军[3] 徐建江 陈蔚 黄一飞[2] 洪佳旭 王婷 李素霞 高华 王敬亭 史伟云 Zhang Ting;Wang Liqiang;Gu Jianjun;Xu Jianjiang;Chen Wei;Huang Yifei;Hong Jiaxu;Wang Ting;Li Suxia;Gao Hua;Wang Jingting;Shi Weiyun(Eye Institute of Shandong First Medical University,Eye Hospital of Shandong First Medical University(Shandong Eye Hospital),State Key Laboratory Cultivation Base,Shandong Provincial Key Laboratory of Ophthalmology,School of Ophthalmology,Shandong First Medical University,Jinan 250021,China;Ophthalmology Division of Chinese PLA General Hospital,Beijing 100853,China;Zhongshan Ophthalmic Center,Sun Yat-sen University,State Key Laboratory of Ophthalmology,Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangdong Provincial Clinical Research Center for Ocular Diseases,Guangzhou 510060,China;Department of Ophthalmology,Eye&ENT Hospital of Fudan University,NHC Key Laboratory of Myopia,Key Laboratory of Myopia,Chinese Academy of Medical Science,Shanghai 200031,China;Eye Hospital of Wenzhou Medical University,National Clinical Research Center for Ocular Diseases,Wenzhou 325027,China)

机构地区：[1]山东第一医科大学附属眼科研究所、山东第一医科大学附属眼科医院(山东省眼科医院)山东省眼科学重点实验室-省部共建国家重点实验室培育基地、山东第一医科大学眼科学院,济南250021 [2]解放军总医院眼科医学部,北京100853 [3]中山大学中山眼科中心、眼科学国家重点实验室、广东省眼科视觉科学重点实验室、广东省眼部疾病临床医学研究中心,广州510060 [4]复旦大学附属眼耳鼻喉科医院眼科、国家卫生健康委员会/中国医学科学院近视眼重点实验室,上海200031 [5]温州医科大学附属眼视光医院、国家眼部疾病临床医学研究中心,温州325027

出　　处：《中华眼科杂志》2023年第4期262-271,共10页Chinese Journal of Ophthalmology

基　　金：山东省重点研发计划(重大科技创新工程)(2022CXGC010505);泰山学者计划(20221110,201812150)。

摘　　要：目的评价领扣型人工角膜移植术治疗高危移植角膜盲的有效性和安全性。方法病例系列研究。前瞻性连续收集2019年7月至2020年1月在山东第一医科大学附属眼科医院、解放军总医院眼科医学部、中山大学中山眼科中心、复旦大学附属眼耳鼻喉科医院眼科和温州医科大学附属眼视光医院就诊且符合条件、拟行领扣型人工角膜移植术的高危移植角膜盲患者。术后随访12个月,观察患者的术后视力,以视力≥0.05为标准计算脱盲率并评定治疗的有效性;记录术后并发症情况、人工角膜在位情况,以评定手术的安全性。结果37例(37只眼)患者纳入研究,男性32例,女性5例;年龄范围为27~72岁。角膜移植手术后角膜植片混浊21只眼(56.8%),眼部化学烧伤8只眼(21.6%),眼部热烧伤5只眼(13.5%),不明原因角膜混浊2只眼(5.4%),角膜融解穿孔1只眼(2.7%)。2只眼于术后3个月退出研究,35只眼完成术后6个月随访,31只眼完成术后12个月随访。术后6个月83.8%术眼视力≥0.05,术后12个月81.8%术眼视力≥0.05。合并青光眼11只眼,术后12个月6只眼视力≥0.05。术后12个月领扣型人工角膜的在位率为100%;5只眼(16.1%)光学镜柱后膜形成,5只眼(16.1%)出现持续性载体角膜上皮缺损,4只眼(12.9%)发生黄斑水肿,4只眼(12.5%)新发青光眼(包括因新发青光眼术后3个月退出研究1只眼),2只眼(6.5%)出现无菌性载体角膜融解,继发无菌性玻璃体炎、感染性角膜炎各1只眼(3.2%)。结论领扣型人工角膜移植术治疗高危移植角膜盲安全且有效,术后多数患者可获得较好视力,且并发症发生率较低。Objective To evaluate the efficiency and safety of collar-button type keratoprosthesis(c-bKPro)implantation for corneal blindness in high-risk transplantation in China.Methods It was a case series study.High-risk corneal blind patients who planned to undergo c-bKPro implantation were prospectively and continuously enrolled in the Eye Hospital of Shandong First Medical University,Ophthalmology Division of Chinese PLA General Hospital,Zhongshan Ophthalmic Center,Department of Ophthalmology in Eye&ENT Hospital of Fudan University,and Eye Hospital of Wenzhou Medical University from July 2019 to January 2020.The cure for blindness and surgical success were assessed based on visual acuity(VA)≥0.05.The complications and keratoprosthesis retention rate were recorded to determine the safety of the surgery.Results Thirty-seven subjects(eyes)were included,of which 32 were male and 5 were female,aged 27 to 72 years old.The indications of c-bKPro implantation were corneal graft failure(21 eyes,56.8%),chemical injury(8 eyes,21.6%),thermal burn(5 eyes,13.5%),unexplained corneal opacity(2 eyes,5.4%),and corneal perforation(1 eye,2.7%).Two patients withdrew from the clinical trial at 3 months postoperatively.Thirty-five patients were followed up for 6 months,and 31 were followed up for 12 months.The VA was≥0.05 in 83.8%of eyes at 6 months and in 81.8%of eyes at 12 months.Among the 11 eyes diagnosed with concurrent glaucoma,6 eyes achieved a VA of≥0.05.At 12 months,the c-bKPro retention rate was 100%.The surgical complications included retroprosthetic membrane formation(5 eyes,16.1%),persistent corneal epithelial defects(5 eyes,16.1%),macular edema(4 eyes,12.9%),new-onset glaucoma(4 eyes,12.5%;including one eye withdrawn from the study at 3 months),sterile corneal melting(2 eyes,6.5%),sterile vitritis(1 eye,3.2%),and infectious keratitis(1 eye,3.2%).Conclusions C-bKPro implantation is an effective and safe option for treating corneal blindness in high-risk transplantation in China.Improved visual outcomes could be achieved i

关 键 词：盲 角膜 假体和植入物 假体植入 有效性研究(主题) 多中心研究(主题) 

分 类 号：R779.65[医药卫生—眼科]