ADVANCED GLAUCOMA INTERVENTION STUDY (AGIS)

这是一份4年半的临床支持申请， 弗吉尼亚大学的中心继续参与 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 眼内干预序列的长期结局 原发性开角型青光眼，初始药物治疗失败 治疗 1988年4月1日至1991年3月31日， 入组了365例患者的425只眼。 每只眼睛都被 随机分配到两个干预序列之一：1） 小梁切除术（T）后氩激光小梁成形术（ALT） 如果T失败，然后是第二个T，如果ALT失败;以及2） 如果ALT失败，ALT后接T，如果ALT失败， 第一个T失败了 这些干预措施得到了医疗保健的补充。 根据需要治疗。 截至1991年3月31日，随访范围为 0至36个月。 不到5%的后续检查， 每隔6个月进行一次，都错过了。 数据正在 收集视功能丧失，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。 预后价值 眼部和非眼部医疗因素和个人因素的影响， 被研究。 研究计划1）继续招募患者 直到790只眼睛被招募，这一目标预计将达到 在4月1日至11月30日期间， 预计将于1992年4月1日至11月30日之间达成， 2)继续患者随访至1996年11月30日，以便 最终随访时间为至少4年至4 2/3年 最多8 2/3年。 一个协调中心收集， 处理、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 监督研究的实施并监测研究结果。 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）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，包括实例 的数据分析。 1988年4月1日至1991年3月31日，该临床中心 入选患者30例38眼。 本申请的细节 该临床中心的资质， 参与，包括我们招募和留住患者的能力 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 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.