ADVANCED GLAUCOMA INTERVENTION STUDY

这是针对晚期青光眼的修订后的销售线索申请 干预研究(AGIS)请求支持参与 乔治城大学。其中包括修订后的AGIS业务 手册和研究计划，并由应用程序补充 来自一个协调中心和其他9个临床中心。这个 本机构参加AGIS的资格如下 详细的，包括病人的可用性。在18个月内 截至1986年6月，96只符合AGIS标准的眼睛接受了 我们，每年有一双合格的眼睛；当地理信息系统开始时，我们 预计每年至少能招收30名学生 招聘。 AGIS的主要目标是系统地评估长期和长期的气候变化。 840只眼连续介入治疗的结果 都没有通过青光眼的初步治疗。符合条件的眼睛 将被随机分配到以下两个干预序列之一： 1)小梁切除术(T)，然后行激光小梁成形术 (ALT)如果T失败，则接着第二个T(如果ALT失败)； 以及2)ALT之后的T应为ALT失败，然后是 如果第一个T失败，则另一个T。未通过分配的眼睛 三次干预的顺序将由其他人员管理 做手术。干预措施将辅之以医疗服务 根据需要进行治疗。在5年的后续行动中，我们计划 确定视功能丧失的程度、失败率 并发症，需要补充治疗。预言家 眼睛、系统、个人和社会因素的价值，包括 合规性，将进行研究。参与机构将坚持 到共同的、具体的定义、资格标准、方法 测量以及诊断、治疗、质量控制、 和行政程序。一个协调中心将 收集、处理和分析学习数据并协调学习 活动；政策和治疗效果监测委员会将 监督研究的进行。

This is a revised lead application for the Advanced Glaucoma Intervention Study (AGIS) requesting support for participation by Georgetown University. It includes the revised AGIS Operations Manual and research plan and is supplemented by applications from a Coordinating Center and 9 other Clinical Centers. The qualifications of this institution to participate in AGIS are detailed, including patient availability. During the 18-month period ending June, 1986 96 AGIS-eligible eyes were treated by us, a rate of 64 eligible eyes per year; when AGIS begins we expect to be able to enroll at least 30 eyes per year of recruitment. The primary goal of the AGIS is to assess systematically the long- range outcomes of sequences of interventions in 840 eyes that have failed initial medical treatment for glaucoma. Eligible eyes will be 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. Eyes that fail the assigned sequence of three interventions will be managed by additional surgery. The interventions will be supplemented with medical treatment as needed. During 5 years of followup we plan to determine degree of visual function loss, rates of failure of complications, and need for supplemental therapy. The prognostic value of ocular, systemic, personal and social factors, including compliance, will be studied. Participating institutions will adhere to common, specified definitions, eligibility criteria, methods of measurement, as well as diagnostic, treatment, quality control, and administrative procedures. A Coordinating Center will collect, process, and analyze study data and coordinate study activities; a Policy and Treatment Effects Monitoring Board will supervise the conduct of the study.