ADVANCE GLAUCOMA INTERVENTION STUDY

这是华盛顿医院中心修改后的申请 参与晚期青光眼干预研究 （AGIS）。 我们参加AGIS的资格是详细的， 包括患者可用性。 在截至2011年12月31日的18个月期间， 1986年6月我院收治符合AGIS条件的病人41例， 每年28名合格患者;当AGIS开始时，我们预计 每年至少招募20只眼睛。 的 提交了详细的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， 最初的青光眼药物治疗失败。 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ALT失败，则随后是第二个T; 和2）ALT失败时，ALT后接T， 如果第一个T失败，另一个T也会失败。 眼睛不合格 三个干预措施的顺序将由额外的 手术 干预措施将辅以医疗 根据需要治疗。 我们计划随访所有患者5年， 确定视功能丧失的程度， 干预和干预序列，并发症发生率， 需要补充治疗 的预后价值 眼部、全身、个人和社会因素，包括 合规，将进行研究。 参与机构将遵守 共同的、具体的定义、资格标准、 测量，以及诊断，治疗，质量控制， 和行政程序。 协调中心将 收集、处理和分析研究数据并协调研究 政策和治疗效果监测委员会将 监督研究的开展。

This is a revised application from the Washington Hospital Center 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 41 AGIS - eligible patients were treated by us, ar rate of 28 eligible patients per year; when AGIS begins, we expect to be able to enroll at least 20 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.