UNIVERSITY OF ILLINOIS ADVANCED GLAUCOMA INTERVENTION

这是一份修改后的申请， 参加高级青光眼干预研究（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年我们治疗了72只符合AGIS条件的眼睛。 存在较大 青光眼咨询中合格眼睛的汇总 伊利诺伊大学在18个月内将游泳池扩大到127个 期 因此，我们预计每年招募35至40只眼睛， 招聘 详细的AGIS研究计划和操作 手册由乔治敦大学牵头提交 应用程序. 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），随后氩激光小梁成形术（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 Illinois to participate in the Advance Glaucoma Intervention Study (AGIS). Our qualifications to participate in AGIS are detailed, including patient availability. During the 18-month period ending June, 1986 72 AGIS-eligible eyes were treated by us. There is a large pool of eligible eyes from the Glaucoma Consultation of the University of Illinois which expands the pool to 127 in an 18 month period. Thus we expect to enroll 35 to 40 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 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.