ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery

作者：DAVID V. SEAL, Peter James Barry, G. Gettinby, Fiona Lees, Magnus Peterson, Crawford W. Revie, Kirk R. Wilhelmus · 发表于：Journal of Cataract & Refractive Surgery · 年份：2006 · DOI：10.1016/j.jcrs.2006.02.014 · 被引用次数：148 · 研究领域：Ocular Infections and Treatments、Legionella and Acanthamoeba research、Ocular Diseases and Behçet’s Syndrome

PURPOSE: 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. SETTING: 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. METHODS: 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. RESULTS: 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. Inform...