Seal David V, Barry Peter, Gettinby George, Lees Fiona, Peterson Magnus, Revie Crawford W, Wilhelmus Kirk R
European Society of Cataract & Refractive Surgeons, Dublin, Ireland.
J Cataract Refract Surg. 2006 Mar;32(3):396-406. doi: 10.1016/j.jcrs.2006.02.014.
To present the development and design of the European Society of Cataract & Refractive Surgeons multicenter study of the prevention of postsurgical infective endophthalmitis after phacoemulsification and to describe the process for its successful implementation and conduct.
Twenty-four ophthalmology units and eye clinics in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, Turkey, and the United Kingdom, with an administrative office in Ireland, coordinating center in England, and data management and statistical unit in Scotland.
This partially masked randomized placebo-controlled multinational clinical study was designed to evaluate prospectively the prophylactic effect of intracameral cefuroxime and/or perioperative topical levofloxacin on postoperative endophthalmitis after cataract surgery. Random allocation was based on a 2 x 2 factorial design that included participating centers as a class variable. Real-time electronic data collection monitored study progress and provided weekly outcome tables, monthly recruitment summaries, and quarterly analytical reports for the study's Data Monitoring Committee, which evaluated the safety and efficacy by Internet-based conferences.
A 2-year lead time was required to meet harmonized standards of clinical research in the European Union, obtain ministerial authorization in 3 countries, gain institutional approvals at 24 hospitals, and procure indemnity insurance for surgical centers. Informed consent instruments, designed to comply with national health policies, were translated into 8 languages. The use of information technology to collect study data enabled the organizers to evaluate individual eligibility at enrollment, adherence with study medications during and after surgery, and postoperative status during follow-up.
This international cooperative study provided the opportunity to estimate the current incidence of endophthalmitis after cataract surgery in Europe and determine whether 1 or both of 2 antimicrobial regimens reduces the risk for postsurgical intraocular infection.
介绍欧洲白内障与屈光手术医师学会关于白内障超声乳化术后预防感染性眼内炎的多中心研究的开展与设计，并描述其成功实施和进行的过程。
奥地利、比利时、德国、意大利、波兰、葡萄牙、西班牙、土耳其和英国的24个眼科单位及眼科诊所，行政办公室位于爱尔兰，协调中心位于英格兰，数据管理和统计单位位于苏格兰。
这项部分设盲的随机安慰剂对照多国临床研究旨在前瞻性评估前房内注射头孢呋辛和/或围手术期局部使用左氧氟沙星对白内障手术后眼内炎的预防效果。随机分配基于2×2析因设计，将参与中心作为分类变量。实时电子数据收集监测研究进展，并为研究的数据监测委员会提供每周结果表、每月招募总结和季度分析报告，该委员会通过基于互联网的会议评估安全性和有效性。
为达到欧盟临床研究的统一标准、在3个国家获得部长级授权、在24家医院获得机构批准以及为手术中心购买责任保险，需要提前2年时间。符合国家卫生政策的知情同意书被翻译成8种语言。利用信息技术收集研究数据使组织者能够在入组时评估个体的合格性、手术期间及术后对研究药物的依从性以及随访期间的术后状态。
这项国际合作研究提供了一个机会，可估计欧洲白内障手术后眼内炎的当前发病率，并确定两种抗菌方案中的一种或两种是否能降低术后眼内感染的风险。
