ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER

眼内炎玻璃体切除术研究协调中心

• 批准号: 3559713
• 负责人: Sheryl F Kelsey
• 金额: $ 27.2万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-07-01 至 1994-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559713
• 关键词: anterior chamber; antibiotics; cataract surgery; clinical trials; cooperative study; drug administration routes; eye pharmacology; human subject; injection /infusion; longitudinal human study; postoperative complications; refractive keratoplasty; uveitis

The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.

眼内炎玻璃体切除术研究（EVS）是一项前瞻性、随机、 多中心临床试验旨在确定睫状体平坦部的作用 玻璃体切除术在细菌性角膜炎初期治疗中的应用 眼内炎 这是作为协调中心的应用程序 对于本研究，主要负责研究组织、数据 管理和统计分析。 随行的研究椅 本申请提供了研究方案，并作为附录包括 手工操作和数据收集表格。 来自纽约大学流行病学数据中心的研究人员 匹兹堡提议继续与研究主席和其他 临床研究者对研究方案、手册 业务和数据收集表格。 协调中心将 负责制定随机方案、中期监测和 向安全性和数据监查委员会报告。 数据将 在IBM的数据中心系统上接收、处理和管理 微型计算机和大型VAX。 试验将比较治疗 眼内炎的治疗策略以及“意向性治疗”， 主要分析方法。 将制定和测试分析方法 在数据采集阶段，最终分析和报告将 在最后一个阶段产生的。