ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份为期4年半的临床支持申请 俄亥俄州立大学中心继续参与 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 原发性开角型青光眼的干预效果 都没有通过初步治疗。1988年4月1日至3月 1991年3月31日AGIS收治435例575只眼。每一只眼睛都是 随机分配到以下两个干预序列之一：1) 小梁切除术(T)后行激光小梁成形术(ALT) 不失败，如果ALT失败，则接着第二个T；以及2)ALT 如果ALT失败，则后跟T，如果 第一个T失败。干预措施辅之以医疗治疗。 视需要而定。截至1991年3月31日，随访时间为0~36个月。 少于5%的后续检查，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 眼科和非眼科医学因素和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 1992年4月1日至11月30日和2)继续患者 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 数据方面的成就，包括数据分析的例子。 1988年4月1日至1991年3月31日期间，该临床中心有 入选52例61只眼。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 研究的定义、标准和程序。

This is an application for 4 1/2 years of support for the clinical center at The Ohio State University 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 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 the ALT fail; and 2) ALT followed by T should ALT fail and followed by a second 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 months 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 data, including examples of data analyses. Between April 1, 1988 and March 31, 1991 this clinical center has enrolled 61 eyes of 52 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.