AGIS CLINIC WHC ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份为临床中心提供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 原发性开角型眼的干预序列结局 最初药物治疗失败的青光眼。 1988年4月1日至 至1991年3月32日，AGIS共纳入435例患者575只眼。 每只眼睛 被随机分配到两个干预序列之一：1） 小梁切除术后氩激光小梁成形术（ALT）应 失败，如果ALT失败，则随后为第二个T;以及2）ALT后为T 如果ALT失败，然后是另一个T，如果第一个T失败。 的 必要时，干预措施还辅之以医疗。 截至 1991年3月31日，随访0 ~ 36个月。 不到五 计划每6个月进行一次的随访检查中， 错过了. 正在收集关于视觉功能丧失、干预 失败、并发症、需要补充药物治疗、依从性 药物治疗和生活质量。 眼外伤的预后价值 并且正在研究非眼部医学因素和个人因素。 的 研究计划：1）继续招募患者直至招募790只眼睛， 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）继续患者随访至1996年11月30日，以便 随访时间最短为4 - 4 2/3年， 最长8 2/3年。 协调中心收集、处理和 分析研究数据并协调研究活动。 策略和 治疗效果监测委员会监督研究的实施， 监测研究结果。 由乔治城大学牵头提交 应用程序是：1）AGIS研究计划，详细说明研究原理， 设计和方法，2）继续招募患者的计划， 后续行动，以及3）迄今为止的研究成果，包括数据示例 分析。 1988年4月1日至1991年4月2日，该临床中心招募了 58例72眼。 本申请详述了 继续参与，包括我们的能力 招募和保留患者并遵守研究定义， 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.