ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份4年半的临床支持申请， 耶鲁大学医学院的中心继续 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， 共纳入435例患者575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)随后进行氩激光小梁成形术（ALT），如果T失败， 如果ALT失败，则第二个T;以及2）ALT后接T 如果ALT失败，然后是另一个T，如果第一个T失败。 干预措施还辅以医疗， needed. 截至1991年3月31日，随访时间为0至36个月。 不到百分之五的随访检查，计划在6个月 间隔，被错过了。 正在收集视觉数据 功能丧失，干预失败，并发症，需要 补充药物治疗，药物治疗依从性，以及 生活质量 眼部和非眼部肿瘤的预后价值 正在研究医疗因素和个人因素。 研究 计划1）继续招募患者，直至790只眼 入学，这一目标预计将在4月1日至 1992年11月30日，和2）继续患者随访，直至 1996年11月30日，因此，后续行动将最终从一个 最少4至4 2/3年，最多8 2/3年。 一 协调中心收集、处理和分析研究数据 并协调研究活动。 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。 由乔治城大学牵头提交 应用有：1）AGIS研究计划，详细研究 原理、设计和方法，2）继续患者计划 招募和随访，以及3）迄今为止的研究成果， 包括数据分析的例子。 1988年4月1日至1991年3月31日，该临床中心 入选41例53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 Yale University School of Medicine 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 53 eyes of 41 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.