ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份为期4年半的临床支持申请 弗吉尼亚大学中心继续参与 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 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425例、365眼以上患者。每一只眼睛都是 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) 如果T失败，第二个T应该失败；以及2) 如果ALT失败，则ALT后面跟着T，如果ALT失败，后面跟着另一个T 第一个T不及格。干预措施辅之以医疗服务。 根据需要进行治疗。截至1991年3月31日，随访期从 0到36个月。不到5%的后续检查， 计划每隔6个月举行一次，已经错过了。数据正在被 关于视觉功能丧失，介入治疗失败， 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。预测价值 眼科和非眼科医学因素和个人因素有 正在研究中。这项研究计划1)继续招募患者 直到790只眼睛入选，这一目标有望实现 在4月1日至11月30日之间，这一目标是 预计在1992年4月1日至11月30日之间达成协议，以及 2)继续患者随访至1996年11月30日，以便 最终随访时间至少为4年至4 2/3年。 最长可达8 2/3年。协调中心收集、 处理、分析学习数据并协调学习 活动。政策和治疗效果监测委员会 监督研究的进行并监测研究结果。 与乔治城大学的申请一同提交的申请如下：1) AGIS研究计划，详细说明研究的基本原理、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，包括实例 数据分析。 1988年4月1日至1991年3月31日期间，该临床中心有 入选30例38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 The University of Virginia 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 425 plus eyes of 365 plus 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, 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 38 eyes of 30 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.