AGIS CONTINUATION CLINICAL CENTER

这是为临床中心提供4年半支持的申请 在西奈医院继续参与正在进行的多中心 高级青光眼干预研究(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4月1日之间， 1988年至1991年3月31日，AGIS收治患者435例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(T)后行Ar激光小梁成形术(ALT) 如果T失败，则第二个T应该ALT失败；以及2)ALT 如果ALT失败，后跟T，如果第一个失败，则后跟另一个T 别失败了。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。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。这项研究计划1)继续患者 招募到790只眼睛入选，这一目标预计将是 在1992年4月1日至11月30日之间联系，以及2)继续接受治疗 跟踪至1996年11月30日，以便后续行动最终将 最短为4年至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和 协调学习活动。一项政策和治疗效果监测 董事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是：1) AGIS研究计划，详细说明研究的理论基础、设计和方法，2) 继续招募和随访患者的计划，以及3)研究 迄今取得的成就，包括数据分析的例子。 从1988年4月1日到1991年3月31日，这个临床中心有 纳入患者24例33眼。本申请详细描述了 该临床中心继续参与的资格， 包括我们招募和留住病人的能力，以及坚持 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 Sinai Hospital 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 value of ocular and nonocular 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 33 eyes of 24 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.