ADVANCED GLAUCOMA INTERVENTION STUDY

这是临床中心提出的为期5年的支持申请 乔治城大学将继续参与正在进行的 多中心晚期青光眼干预研究(AGIS)。它是领头羊 申请该项研究，并附有10份申请书 临床中心和协调中心。 AGIS的主要目标是系统地评估 原发性开角眼的序贯干预效果分析 初次治疗失败的青光眼。在4月1日之间， 1988年和1991年4月30日，AGIS收治了454例600只眼。每个人 眼睛被随机分配到以下两种干预序列之一：1) 小梁切除术(T)后行激光小梁成形术(ALT) 如果ALT失败，则按下ALT，然后按第二个T；以及2)按ALT后按T 如果Alt下降，如果第一个T下降，则紧随其后的是另一个T。这个 根据需要进行干预并辅之以医疗治疗。自.起 1991年1月31日，随访0~34个月，不到1个月 %的患者失去了随访，约2%的患者 访问被错过了。正在收集有关视觉功能的数据 丢失、介入失败、并发症、需要补充医疗服务 治疗、对药物治疗的依从性和生活质量。这个 眼部和非眼部医学因素及个人因素对预后的影响 相关因素正在研究中。我们计划1)继续招募病人 直到790只眼睛登记，这是我们预计在4月之间达到的目标 1和1992年11月30日，以及2)继续患者随访至11月 30,1996年，因此，后续行动将至少为4年至4 2/3年 (取决于注册完成时间)最多为8 2/3 好几年了。协调中心收集、处理和分析研究 数据和协调学习活动。一项政策和治疗效果 监督委员会监督研究的进行和监督研究 结果。与乔治敦大学的申请一同提交的是： 1)AGIS研究计划，详细说明研究原理、设计和 方法，2)迄今的研究成果，包括数据实例 分析，以及3)计划继续招募患者、跟踪和 写报告。 该应用程序描述了此中的合作者的资格 多中心研究，特别是详细说明了 乔治敦大学临床中心，由母公司组成 和一个卫星中心。1988年4月1日至1991年4月30日期间 乔治城大学AGIS临床中心招收了39只眼睛中的50只 患者；其中，卫星中心贡献了13只眼中的16只眼 病人。

This is an application for 5 years of support from the Clinical Center at Georgetown University to continue participation in the ongoing multicenter Advanced Glaucoma Intervention Study (AGIS). It is the lead application for the study and is accompanied by applications from 10 Clinical Centers and a Coordinating Center. The principal goal of AGIS is to assess systematically the long-range outcomes of sequences of Interventions In eyes with primary open-angle glaucoma that have failed initial medical treatment. Between April 1, 1988 and April 30, 1991 AGIS has enrolled 600 eyes of 454 patients. Each eye has been randomly assigned to one of two intervention sequences: 1) trabeculectomy (T) followed by argon laser trabeculoplasty (ALT) should T fall and followed by a second T should ALT fail; and 2) ALT followed by T should ALT fall and followed by another T should the first T fall. The interventions are supplemented with medical treatment as needed. As of January 31, 1991, with follow-up ranging from 0 to 34 months, less than 1 percent of patients had been lost to follow-up and about 2 percent of visits had been missed. Data are being collected on visual function loss, intervention failure, complications, need for supplemental medical therapy, compliance with medical therapy, and quality of life. The prognostic value of ocular and non-ocular medical factors and personal factors is being studied. We plan to 1) continue patient recruitment until 790 eyes are enrolled, a goal that we expect to reach between April 1 and November 30, 1992, and 2) continue patient follow-up until November 30, 1996, so that follow-up will range from a minimum of 4 to 4 2/3 years (depending upon when enrollment is completed) to a maximum of 8 2/3 years. The Coordinating Center collects, processes, and analyzes study data and coordinates study activities. A Policy and Treatment Effects Monitoring Board supervises the conduct of the study and monitors study outcomes. Submitted with the Georgetown University lead application are: 1) the AGIS research plan, detailing study rationale, design, and methods, 2) study accomplishments to date, including examples of data analysis, and 3) plans for continued patient recruitment, follow-up, and report writing. The application describes the qualifications of the collaborators in this multicenter study and in particular, details the qualifications of the Georgetown University Clinical Center which consists of a parent facility and a satellite center. Between April 1, 1988 and April 30, 1991 the Georgetown University AGIS Clinical Center has enrolled 50 eyes of 39 patients; of these, the satellite center contributed 16 eyes of 13 patients.