AGIS CLINIC WHC ADVANCED GLAUCOMA INTERVENTION STUDY

这是为临床中心提供4年半支持的申请 在华盛顿医院中心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 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1988年4月1日之间 1991年3月32号，AGIS收治了435例575只眼。每只眼睛 被随机分配到以下两个干预序列之一：1) 小梁切除术(T)后行激光小梁成形术(ALT) 失败，如果ALT失败，则紧跟第二个T；以及2)ALT和T 如果ALT失败，则在第一个T失败的情况下跟随另一个T。这个 根据需要进行干预并辅之以医疗治疗。自.起 1991年3月31日，随访0~36个月。不到五个 计划每6个月进行一次的后续检查的百分比 打偏了。正在收集有关视觉功能丧失、干预的数据 失败、并发症、需要补充药物治疗、依从性 用药物治疗，并提高生活质量。眼科疾病的预后价值 非眼科医学因素和个人因素正在研究中。这个 研究计划1)继续招募患者，直到790只眼睛入选， 这一目标预计将在4月1日至11月30日之间实现， 1992年和2)继续对患者进行随访，直到1996年11月30日，以便 随访最终将从最少4年到4 2/3年到 最长为8 2/3年。协调中心收集、处理和 分析学习数据，协调学习活动。一项政策和 治疗效果监测委员会监督研究的进行和 监控研究结果。提交给乔治敦大学的领导 应用是：1)AGIS研究计划，详细说明研究原理， 设计和方法，2)继续招募病人的计划和 后续行动，以及3)迄今的研究成果，包括数据实例 分析。 1988年4月1日至1991年4月2日，该临床中心已招收 58例72眼。本申请详细说明了这些资格 这个临床中心的持续参与，包括我们的能力 招募和留住病人，并遵守研究定义， 标准和程序。

This is an application for 4 1/2 years of support for the clinical center at the Washington Hospital Center 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 32, 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 April 2, 1991 this clinical center has enrolled 72 eyes of 58 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.