ADVANCE GLAUCOMA INTERVENTION STUDY

这是密歇根大学修改后的申请 晚期青光眼干预研究（Advanced Glaucoma Intervention Study，AGIS） 我们参与AGIS的资格详细说明，包括 患者可用性。 在截至6月的18个月期间， 1986年，26例36眼符合AGIS条件的患者接受了Dr. Lichter，每年有24只合格眼睛。 此外 大约有相同数量的合格患者接受了治疗 由共同主要研究者和我们的青光眼诊所;因此， 我们预计在第一年至少招募25名患者。 的 提交详细的AGIS研究计划和操作手册 乔治城大学的申请 AGIS的主要目标是系统地评估长期的 在840只眼睛中进行干预序列的范围结果， 青光眼的早期药物治疗失败。 合格的眼睛 将被随机分配到两个干预序列之一; 1） 小梁切除术（T），然后进行氩激光小梁成形术（ALT） 如果T失败，然后是第二个T，如果ALT失败;以及2） 如果ALT失败，ALT后接T，然后再接一个T 如果第一个T失败了。 未通过指定序列的眼睛 三种干预措施将通过额外的手术进行管理。 的 干预措施将辅之以医疗， needed. 我们计划对所有患者进行为期五年的随访， 视功能丧失程度、干预失败率和 干预序列、并发症发生率以及 补充治疗 眼部、全身、 将研究个人和社会因素，包括遵守情况。 参与机构将遵守共同的、具体的 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 分析研究数据并协调研究活动;政策和 治疗效果监察委员会将监督 书房

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.