ADVANCED GLAUCOMA INTERVENTION STUDY

高级青光眼干预研究

• 批准号: 3559430
• 负责人: REAY H BROWN
• 金额: $ 15.14万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-01 至 1992-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559430
• 关键词: cooperative study; disease /disorder prevention /control; eye agent; eye disorder diagnosis; glaucoma; health care quality; human subject; human therapy evaluation; longitudinal human study; postoperative complications; prognosis; therapy compliance; trabeculotomy; vision disorders

This is a revised application from Emory University 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, 136 eyes of 99 AGIS-eligible patients were treated by us, a rate of 88 eligible eyes per year; when AGIS begins we expect to be able to enroll at least 50 eyes/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.

这是埃默里大学（Emory University）的修订申请 在晚期青光眼干预研究（AGIS）中。 我们的 参加AGIS的资格已详细，包括 患者的可用性。 在截至6月的18个月期间， 1986年，我们治疗了99名AGIS符合条件的患者的136眼 每年88岁合格的眼睛的速度；当Agis开始时，我们期望 能够注册至少50只眼睛/年的招募。 这 提交了详细的AGIS研究计划和操作手册 与乔治敦大学的铅申请。 AGI的主要目标是系统地评估长期 在840只眼睛中的干预序列范围范围 初始治疗青光眼的治疗失败。 合格的眼睛 将随机分配给两个干预序列之一； 1） 小梁切除术（T），然后是氩激光小梁成形术（ALT） 如果t失败，然后第二个t应该失败；和2） alt接下来是T alt Alt失败，然后是另一个T 第一个t应该失败。 失败的眼睛未分配的顺序 三项干预措施将通过其他手术来管理。 这 干预措施将补充医疗 需要。 我们计划跟随所有患者五年来确定 视觉功能损失程度，干预措施的失败率和 干预序列，并发症的速度和需求 补充疗法。 眼，全身性的预后价值 将研究个人和社会因素，包括合规性。 参与的机构将遵守常见，指定 定义，资格标准，测量方法 作为诊断，治疗，质量控制和行政 程序。 协调中心将收集，流程和 分析研究数据并协调研究活动；政策和 治疗效果监测委员会将监督行为 研究。