ADVANCED GLAUCOMA INTERVENTION STUDY

高级青光眼干预研究

• 批准号: 3559476
• 负责人: MARSHALL N CYRLIN
• 金额: $ 12.7万
• 依托单位: SINAI HOSPITAL OF DETROIT
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-05 至 1991-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559476
• 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 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.

这是底特律西奈医院的修订申请 参加晚期青光眼干预研究（AGIS）。 我们参加AGIS的资格已详细，包括 患者的可用性。 在24个月的结局 1986年12月，我们对102只符合AGIS符合AGIS的眼睛被我们待遇 平均每年51；因此，我们希望每人注册20至25只眼睛 招募年。 详细的AGIS研究计划和 运营手册已与乔治敦大学提交 线索应用。 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 初步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）应该失败，然后第二个t应该失败； 2）Alt接着T Alt会失败，然后是 另一个T应该失败。 未分配的眼睛 三个干预措施的顺序将由其他 外科手术。 干预措施将补充医疗 根据需要进行处理。 我们计划跟随所有患者5年 确定视觉功能损失程度，失败率 干预和干预序列，并发症率， 并需要补充治疗。 预后价值 眼，系统，个人和社会因素，包括 合规性将被研究。 参与机构将遵守 对于常见的指定定义，资格标准，方法 测量以及诊断，治疗，质量控制， 和行政程序。 协调中心将 收集，处理和分析研究数据并协调研究 活动;政策和治疗效果监测委员会将 监督研究的行为。