ADVANCE GLAUCOMA INTERVENTION STUDY

这是密歇根大学修改后的申请 参与晚期青光眼干预研究(AGIS)。 我们参加AGIS的资格是详细的，包括 病人有空时间。在截至6月的18个月期间， 1986年，26例(36只眼)符合AGIS标准的患者接受了DR治疗。 利希特，每年24只符合条件的眼睛。此外 接受治疗的符合条件的患者数量大致相同 由联合首席调查员和我们的青光眼诊所；因此 我们预计在第一年至少招收25名患者。这个 提交详细的AGIS研究计划和操作手册 乔治城大学的领衔申请。 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 青光眼的初步治疗都失败了。符合条件的眼睛 将被随机分配到两个干预序列中的一个；1) 小梁切除术(T)，然后行激光小梁成形术(ALT) 如果T失败，则第二个T将失败；以及2) 如果ALT失败，则按ALT后按T，然后按另一个T 如果第一个T失败了。眼睛没有通过指定的序列 三项干预措施将通过额外的手术进行管理。这个 干预措施将辅之以医疗，如 需要的。我们计划对所有患者进行五年的跟踪调查，以确定 视功能丧失程度、干预失败率和 干预顺序、并发症发生率和是否需要 补充治疗。眼部，全身， 将对个人、社会因素，包括合规进行研究。 参与机构将坚持共同、特定的 定义、资格标准、衡量方法以及 作为诊断、治疗、质量控制和管理 程序。协调中心将收集、处理和 分析研究数据和协调研究活动；政策和 治疗效果监测委员会将监督 这项研究。

This is a revised application from the University of Michigan to participate in the Advanced Glaucoma Intervention Study (AGIS). Our qualifications to participate in AGIS are detailed, including patient availability. During the 18-month period ending June, 1986, 36 eyes of 26 AGIS-eligible patients were treated by Dr. Lichter, an annual rate of 24 eligible eyes per year. In addition approximately an equal number of eligible patients were treated by the co-principle investigator and by our glaucoma clinic; thus we expect to enroll at least 25 patients during the first year. The detailed AGIS research plan and Operations Manual are submitted with the Georgetown University lead application. 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 of 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. We plan to follow all patients for five years to determine degree of visual function loss, rates of failure of interventions and intervention sequences, rates 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.