CENTRAL VEIN OCCLUSION STUDY, PARTICIPATING CENTER

中央静脉闭塞研究，参与中心

• 批准号: 3559673
• 负责人: FRONCIE A GUTMAN
• 金额: $ 9.82万
• 依托单位: CLEVELAND CLINIC FOUNDATION
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-03-01 至 1994-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559673
• 关键词: angiogenesis; clinical trials; cooperative study; disease /disorder prevention /control; edema; eye laser surgery; eye surgery; glaucoma; human subject; human therapy evaluation; longitudinal human study; photocoagulation therapy; prognosis; retina circulation disorder; retina disorder; vein occlusion

The proposed study will be a national collaborative randomized clinical trial of photocoagulation treatment for central retinal vein occlusion. The study will be conducted at 8-10 clinical centers with the Coordinating Center at Scott and White Hospital (Texas A&M University), and the Reading Center at Bascom Palmer Eye Institute (University of Miami). This application is for a particular center. Patients will be entered into four study groups: Non-perfused (Group N), Macular Edema (Group M), Perfused (Group P), and Indeterminant (Group I). Eyes in the first two groups will be randomly assigned to photocoagulation and a control group respectively. Patients in the latter two groups will be followed for natural history and for possible later entry into the randomized study. Estimated recruitment is 240 for Group N, 160 for Group I, and 400 for Group P. Approximately 50% of these patients will also qualify for Group M. Patients will be recruited for the first three years of this five year study; all patients will be followed until study termination. The study is designed to provide information concerning the efficacy of photocoagulation in preventing neovascular glaucoma in eyes with central retinal vein occlusion and retinal non- perfusion and the usefulness of photocoagulation in preserving visual acuity in eyes with central vein occlusion and macular edema. Data will be collected at baseline and at each follow up visit and forwarded to the Coordinating Center for analysis. Photographs will be reviewed at the Reading Center to determine eligibility and adequacy of treatment. A Data Monitoring Committee will review interim results every six months.

拟议的研究将是一项全国性的协作随机研究 视网膜中央光凝治疗的临床试验 静脉闭塞。这项研究将在8点至10点临床进行 斯科特和怀特医院协调中心 (德克萨斯A&M大学)和巴斯康姆阅读中心 帕尔默眼科研究所(迈阿密大学)。此应用程序是 对于一个特定的中锋。 患者将被分成四个研究组：非灌注组 (N组)、黄斑水肿(M组)、灌注组(P组)和 不确定(第I组)。前两组的眼睛将是 随机分为光凝组和对照组 分别进行了分析。后两组患者将接受随访 对于自然历史和后来可能进入的 随机研究。N组160人的估计招聘人数为240人 I组400人，P组400人。其中约50% 患者也将有资格进入M组。患者将被招募 在这项为期五年的研究的前三年，所有患者都将 一直跟踪到研究结束。 这项研究旨在提供有关 光凝术预防新生血管性青光眼的疗效观察 视网膜中央静脉阻塞和非视网膜病变的眼 灌流和光凝在保存中的作用 中心静脉阻塞合并黄斑病变的视力 浮肿。数据将在基线和每次跟进时收集 访问并转发到协调中心进行分析。 照片将在阅读中心进行审查，以确定 治疗的资格和充分性。A数据监控 委员会将每六个月审查一次中期业绩。