CENTRAL VEIN OCCLUSION STUDY, PARTICIPATING CENTER

中央静脉闭塞研究，参与中心

• 批准号: 3559671
• 负责人: FRONCIE A GUTMAN
• 金额: $ 9.58万
• 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 1993-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559671
• 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.

这项拟议的研究将是一项全国性的合作随机研究， 光凝治疗中央视网膜病变的临床研究 静脉闭塞 研究将在8-10个临床 斯科特和白色医院的协调中心 （德克萨斯农工大学）和巴斯科姆的阅读中心 帕尔默眼科研究所（迈阿密大学）。 本申请是 一个特定的中心。 患者将进入四个研究组：非灌注组 （N组）、黄斑水肿（M组）、灌注（P组）和 不确定性（I组）。 前两组的眼睛 随机分为光凝组和对照组 分别 将对后两组患者进行随访 自然历史和可能的后期进入 随机研究。 N组预计招募240人， 组I和组P分别为400和400。 患者也有资格进入M组。 招募患者 在这项为期五年的研究的前三年，所有患者都将 随访至研究终止。 该研究旨在提供有关 光凝预防新生血管性青光眼的疗效观察 在视网膜中央静脉阻塞和视网膜非 灌注和光凝在保存中的作用 黄斑中心静脉阻塞眼视力 水肿 将在基线和每次随访时收集数据 访问并转交协调中心进行分析。 照片将在阅读中心进行审查，以确定 资格和充分的治疗。 数据监查 委员会将每六个月审查一次中期业绩。