AGIS CONTINUATION PIEDMONT HOSPITAL

这是一份为临床中心提供4年半支持的申请 在皮埃蒙特医院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。 在4月1日， 1988年至1991年3月31日，AGIS共纳入435例患者575只眼。 每个 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。 的预测价值 眼部和非眼部的医学因素和个人因素正在被 研究了 该研究计划1）继续招募患者，直至790 这一目标预计将在4月1日至12日期间实现。 和1992年11月30日，和2）继续患者随访，直至 1996年11月30日，以便后续行动最终将从最低限度的 4至4 2/3年，最多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 政策和治疗效果监测委员会监督 开展研究并监测研究结果。 的情况下提交 乔治城大学牵头的申请有：1）AGIS研究计划， 详细说明研究原理、设计和方法，2） 持续的患者招募和随访，以及3）研究成果 迄今为止，包括数据分析的示例。 1988年4月1日至1991年3月31日，该临床中心 入选患者17例20眼。 本申请详述了 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 Piedmont 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 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 20 eyes of 17 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.