ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份来自临床中心的5年支持申请， 乔治敦大学继续参与正在进行的 多中心晚期青光眼干预研究（AGIS）。 它是主角 申请研究，并附有申请从10 临床中心和协调中心。 AGIS的主要目标是系统地评估 原发性开角型青光眼的干预序列结局 最初药物治疗失败的青光眼。 在4月1日， 1988年至1991年4月30日，AGIS共纳入454例患者600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 如果ALT失败，则下降，然后是第二个T;以及2）ALT，然后是T 如果ALT下降，然后是另一个T，如果第一个T下降。 的 必要时，干预措施还辅之以医疗。截至 1991年1月31日，随访0 - 34个月，不到1个月 %的患者失访， 访问被错过了。 正在收集视觉功能的数据 损失、干预失败、并发症、需要补充医疗 治疗、药物治疗依从性和生活质量。 的 眼部和非眼部医学因素的预后价值以及个人 因素正在研究中。 我们计划1）继续招募患者 直到790只眼睛被招募，我们预计在4月25日和26日之间达到这一目标。 1和1992年11月30日，和2）继续患者随访至1992年11月 30日，1996年，以便随访将从最少4年到4 2/3年不等 （取决于注册完成的时间）最多8 2/3 年 协调中心收集、处理和分析研究 数据和协调研究活动。 A政策与治疗效果 监查委员会监督研究的实施并监查研究 结果。 与乔治城大学领导申请一起提交的是： 1)AGIS研究计划，详细说明研究原理、设计和 方法，2）研究迄今为止的成就，包括数据的例子 分析，以及3）持续患者招募、随访和 写报告。 申请书描述了合作者的资格， 多中心研究，特别是详细说明了 乔治城大学临床中心，包括一个母机构 一个卫星中心。 1988年4月1日至1991年4月30日， 乔治城大学AGIS临床中心共招募了39只眼睛中的50只眼睛 患者;其中，卫星中心贡献了13只眼睛中的16只 患者

This is an application for 5 years of support from the Clinical Center at Georgetown University to continue participation in the ongoing multicenter Advanced Glaucoma Intervention Study (AGIS). It is the lead application for the study and is accompanied by applications from 10 Clinical Centers and a Coordinating Center. 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 April 30, 1991 AGIS has enrolled 600 eyes of 454 patients. Each eye has been randomly assigned to one of two intervention sequences: 1) trabeculectomy (T) followed by argon laser trabeculoplasty (ALT) should T fall and followed by a second T should ALT fail; and 2) ALT followed by T should ALT fall and followed by another T should the first T fall. The interventions are supplemented with medical treatment as needed. As of January 31, 1991, with follow-up ranging from 0 to 34 months, less than 1 percent of patients had been lost to follow-up and about 2 percent of visits had 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 non-ocular medical factors and personal factors is being studied. We plan to 1) continue patient recruitment until 790 eyes are enrolled, a goal that we expect to reach between April 1 and November 30, 1992, and 2) continue patient follow-up until November 30, 1996, so that follow-up will range from a minimum of 4 to 4 2/3 years (depending upon when enrollment is completed) to a maximum of 8 2/3 years. The 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) study accomplishments to date, including examples of data analysis, and 3) plans for continued patient recruitment, follow-up, and report writing. The application describes the qualifications of the collaborators in this multicenter study and in particular, details the qualifications of the Georgetown University Clinical Center which consists of a parent facility and a satellite center. Between April 1, 1988 and April 30, 1991 the Georgetown University AGIS Clinical Center has enrolled 50 eyes of 39 patients; of these, the satellite center contributed 16 eyes of 13 patients.