ADVANCED GLAUCOMA INTERVENTION STUDY

这是底特律西奈医院修改后的申请 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。在截至的24个月期间内 1986年12月，我们对102只符合AGIS标准的眼睛进行了治疗 平均每年51只；因此，我们预计每年将招收20至25只眼睛 招聘的年份。详细的AGIS研究计划和 操作手册与乔治敦大学一起提交 牵头申请。 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 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。我们计划对所有患者进行为期5年的跟踪调查 确定视功能丧失的程度、失败率 干预措施和干预顺序、并发症发生率、 需要补充治疗。高血压性脑脊髓炎的预后价值 目视、系统、个人和社会因素，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 application from Sinai Hospital of Detroit to participate in the Advanced Glaucoma Intervention Study (AGIS). Our qualifications to participate in AGIS are detailed, including patient availability. During the 24-month period ending December, 1986, 102 AGIS-eligible eyes were treated by us for an average of 51 per year; thus we expect to enroll 20 to 25 eyes per year of recruitment. 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 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. We plan to follow all patients for 5 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.