ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份为期4年半的临床支持申请 耶鲁大学医学院中心将继续 参与正在进行的多中心晚期青光眼 干预研究(AGIS)。 AGIS的主要目标是系统地评估 一系列干预措施治疗青光眼的远期疗效 初次治疗失败的原发性开角型青光眼 治疗。在1988年4月1日至1991年3月31日期间，AGIS 入选435名患者575只眼。每只眼睛都是随机的 分配给以下两种干预序列之一：1)小梁切除术 (T)如果T失败，则随后进行Ar激光小梁成形术(ALT)和 如果ALT失败，则后跟第二个T；以及2)ALT后跟T 如果ALT失败，则在第一个T失败的情况下跟随另一个T。 干预措施辅之以医疗治疗，如 需要的。截至1991年3月31日，随访时间为0~36个月。 少于5%的后续考试，计划在6个月内进行 间歇，已经错过了。数据正在以可视方式收集 功能丧失、介入失败、并发症、需要 补充药物治疗，依从性药物治疗，以及 生活质量。眼球与非眼球疾病的预后价值 医疗因素和个人因素正在研究中。这项研究 计划1)继续招募病人，直到790只眼睛 注册，这一目标预计将在4月1日至 1992年11月30日，和2)继续患者随访，直到 1996年11月30日，因此后续行动最终将从 最短为4至4 2/3年，最长为8 2/3年。一个 协调中心收集、处理和分析研究数据 并协调学习活动。一项政策和治疗效果 监督委员会监督研究的进行，并监督 研究结果。提交给乔治敦大学的领导 具体应用有：1)AGIS研究计划，详细研究 原理、设计和方法，2)继续患者的计划 招募和后续行动，以及3)迄今的研究成果， 包括数据分析的例子。 1988年4月1日至1991年3月31日期间，该临床中心有 入选41例53只眼。本申请详细说明 这家临床中心有资格继续 参与，包括我们招募和留住患者的能力 并坚持研究定义、标准和程序。

This is an application for 4 1/2 years of support for the clinical center at Yale University School of Medicine to continue participation in the ongoing multicenter Advanced Glaucoma Intervention Study (AGIS). 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 March 31, 1991 AGIS has enrolled 575 eyes of 435 patients. Each eye has been randomly assigned to one of two intervention sequences: 1) trabeculectomy (T) followed by argon laser trabeculoplasty (ALT) should T fail and followed by a second T should ALT fail; and 2) ALT followed by T should ALT fail and followed by another T should the first T fail. The interventions are supplemented with medical treatment as needed. As of March 31, 1991 follow-up ranged from 0 to 36 months. Less than five percent of follow-up exams, scheduled at 6-month intervals, have 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 values of ocular and non-ocular medical factors and personal factors are being studied. The study plans 1) to continue patient recruitment until 790 eyes are enrolled, a goal that is expected to be reached between April 1 and November 30, 1992, and 2) to continue patient follow-up until November 30, 1996, so that follow-up will ultimately range from a minimum of 4 to 4 2/3 years to a maximum of 8 2/3 years. A 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) the plans for continued patient recruitment and follow-up, and 3) study accomplishments to date, including examples of data analyses. Between April 1, 1988 and March 31, 1991 this clinical center has enrolled 53 eyes of 41 patients. The present application details the qualifications of this clinical center for continued participation, including our ability to recruit and retain patients and to adhere to the study definitions, criteria, and procedures.