ADVANCED GLAUCOMA INTERVENTION STUDY

高级青光眼干预研究

• 批准号: 2710956
• 负责人: MARSHALL N CYRLIN
• 金额: $ 3.38万
• 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 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2710956
• 关键词: clinical trials; cooperative study; eye laser surgery; functional ability; glaucoma; glaucoma surgery; human subject; human therapy evaluation; longitudinal human study; outcomes research; postoperative complications; prognosis; therapy compliance; trabeculotomy; vision disorders

This is an application for 4 1/2 years of support for the clinical center at Sinai Hospital to continue participation in the ongoing multicenter Advanced Glaucoma Intervention Study (AGIS). The principal goal of AGIS is to assess systematically the long-range outcomes of sequences of interventions in eyes with primary open-angle glaucoma that have failed initial medical treatment. Between April 1, 1988, and March 31, 1991, AGIS has enrolled 575 eyes of 435 patients. Each eye has been 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. The interventions are supplemented with medical treatment as needed. As of March 31, 1991, follow-up ranged from 0 to 36 months. Less than five percent of follow-up exams, scheduled at 6-month intervals, have been missed. Data are being collected on visual function loss, intervention failure, complications, need for supplemental medical therapy, compliance with medical therapy, and quality of life. The prognostic value of ocular and nonocular medical factors and personal factors are being studied. The study plans 1) to continue patient recruitment until 790 eyes are enrolled, a goal that is expected to be reached between April 1 and November 30, 1992, and 2) to continue patient follow-up until November 30, 1996, so that follow-up will ultimately range from a minimum of 4 to 4 2/3 years to a maximum of 8 2/3 years. A coordinating center collects, processes, and analyzes study data and coordinates study activities. A Policy and Treatment Effects Monitoring Board supervises the conduct of the study and monitors study outcomes. Submitted with the Georgetown University lead application are: 1) the AGIS research plan, detailing study rationale, design, and methods, 2) the plans for continued patient recruitment and follow-up, and 3) study accomplishments to date, including examples of data analyses. Between April 1, 1988, and March 31, 1991, this clinical center has enrolled 33 eyes of 24 patients. The present application details the qualifications of this clinical center for continued participation, including our ability to recruit and retain patients and to adhere to the study definitions, criteria, and procedures.

这是对临床中心的4 1/2年支持的应用 在西奈医院继续参加正在进行的多中心 晚期青光眼干预研究（AGIS）。 AGI的主要目标是系统地评估远程 主开角的眼睛中干预序列的结果 初始治疗失败的青光眼。在4月1日之间 1988年和1991年3月31日，Agis招募了435名患者的575只眼睛。 每只眼睛都被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失败并接下来是第二个t，则应失败； 2）Alt 其次是T alt失败，然后再进行另一个T t失败。 干预措施补充了医疗 需要。 截至1991年3月31日，随访时间为0到36个月。 不到5％的随访考试，预定为6个月 间隔，被错过了。 正在收集有关视觉功能的数据 损失，干预失败，并发症，需要补充医疗 治疗，遵守医疗疗法和生活质量。 这 眼和非眼医学因素和个人的预后价值 正在研究因素。 研究计划1）继续病人 招募直到790只眼睛注册为止，这一目标有望是 达到1992年4月1日至11月30日之间，以及2）继续患者 随访到1996年11月30日，以最终的随访 从至少4到4 2/3年到最高8 2/3年不等。 一个 协调中心收集，过程和分析研究数据，并 坐标研究活动。 政策和治疗效果监控 董事会监督研究的行为，并监视研究结果。 与乔治敦大学的铅申请提交的是：1） AGIS研究计划，详细研究基本原理，设计和方法，2） 持续招募和随访的计划以及3）研究 迄今为止的成就，包括数据分析的示例。 在1988年4月1日至1991年3月31日之间，这个临床中心有 24例患者的33只眼睛注册。 本申请详细介绍了 这个临床中心继续参与的资格， 包括我们招募和保留患者并遵守的能力 研究定义，标准和程序。