ADVANCED GLAUCOMA INTERVENTION STUDY

这是一份4年半的临床支持申请， 中心在俄亥俄州州立大学继续参与在 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 在原发性青光眼患者中进行干预的长期结局 最初药物治疗失败的开角型青光眼。 从1988年4月1日至1991年3月31日，AGIS共招募了575只眼 435名患者 每只眼睛被随机分配到两个 干预顺序：1）小梁切除术（T），然后氩气 激光小梁成形术（ALT）应失败，然后进行第二次 如果ALT失败，则为T; 2）如果ALT失败，则ALT后跟T， 如果第一个T失败，则跟随第二个T。 的干预措施 根据需要辅以医疗。 截至3月31日， 1991年随访0~36个月。 不到百分之五 的随访检查，安排在6个月的间隔，已经 错过了. 正在收集视觉功能丧失的数据， 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， 正在研究个人因素。 研究计划1）继续进行 招募患者直至招募790只眼，目标是 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52例患者61只眼。 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 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 date, 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.