ADVANCED GLAUCOMA INTERVENTION STUDY

高级青光眼干预研究

• 批准号: 2161003
• 负责人: REAY H BROWN
• 金额: $ 13.81万
• 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 1997-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2161003
• 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

This is an application for 4 1/2 years of support for the clinical center at The Ohio State University 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 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 the ALT fail; and 2) ALT followed by T should ALT fail and followed by a second 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 months 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 values of ocular and non-ocular 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 61 eyes of 52 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.

这是为临床支持4 1/2年的申请 俄亥俄州立大学的中心继续参加 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 双眼干预措施的远程结果 初始治疗失败的开角青光眼。 在1988年4月1日至1991年3月31日之间，Agis注册了575眼 435例患者。 每只眼睛都被随机分配给两只 干预序列：1）小梁切除术（T），然后是氩 激光小梁成形术（ALT）应失败，然后再一次 t应该失败； 2）Alt接着T Alt应该失败，并且 其次是第二个T应该失败。 干预措施 根据需要补充医疗。 截至3月31日， 1991年的随访时间为0到36个月。 不到5％ 安排以6个月间隔进行的后续考试已经 错过。 正在收集有关视觉功能丢失的数据， 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 眼和非眼医学因素的预后价值以及 正在研究个人因素。 研究计划1）继续 患者招募直到790只眼睛注册，一个目标是 预计将在1992年4月1日至11月30日之间达到 2）继续患者随访至1996年11月30日，以便 随访最终将最少4到4 2/3年 最多8 2/3年。 协调中心收集， 过程，并分析研究数据和坐标研究 活动。 政策和治疗效果监测委员会 监督研究的行为和监视研究结果。 与乔治敦大学铅申请提交的是：1） AGIS研究计划，详细详细介绍了研究原理，设计和 方法，2）继续招募患者的计划和 跟进和3）迄今为止研究成就，包括示例 数据分析。 在1988年4月1日至1991年3月31日之间，这个临床中心有 52例患者的61只眼睛注册。 当前的申请详细信息 这个临床中心的资格继续 参与，包括我们招募和留住患者的能力 并遵守研究定义，标准和程序。