CENTRAL VEIN OCCLUSION STUDY -- PARTICIPATING CENTER

中央静脉闭塞研究——参与中心

• 批准号: 3559389
• 负责人: DANIEL FINKELSTEIN
• 金额: $ 17.32万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/3559389
• 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

This application is for a participating center of a national collaborative randomized controlled clinical trial of photocoagulation treatment for central vein occlusion. The study will be conducted at 8 clinical centers with the Reading Center at the Bascom Palmer Eye Institute (University of Miami), and the Coordinating Center at Scott and White Hospital in Temple, Texas (Texas A&M University). 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 treatment and a control group. Patients in Groups P and I will be followed for natural history and for possible later entry into the randomized study. Estimated recruitment is 240 patients in Group N; 480 in Group P and 240 in Group I. Approximately 50% of these patients will also qualify for Group M. Patients will be recruited for the first 3 years of this 5 year study, and all patients will be followed until termination of the study. The study is designed to provide information regarding whether or not photocoagulation is efficacious in preventing neovascular glaucoma in eyes with central vein occlusion and retinal non- perfusion, and whether or not photocoagulation is useful in preserving visual acuity in eyes with central vein occlusion and macular edema. Information collected at base line and each follow-up visit will be forwarded to the Coordinating Center for processing and analysis. Photographs will be reviewed at the Reading Center to ascertain eligibility and adequacy of treatment. A Data Monitoring Committee will review interim results of the study every 6 months.

本申请适用于国家级参与中心 协作随机对照临床试验 中央静脉阻塞的光凝治疗。 研究 将在 8 个临床中心进行，阅读中心位于 巴斯科姆帕尔默眼科研究所（迈阿密大学）和 德克萨斯州坦普尔斯科特和怀特医院协调中心 （德克萨斯农工大学）。 患者将参加四项研究 组：非灌注（N 组）；黄斑水肿（M组）； 灌注（P组）；和不确定（第一组）。 眼睛在第一 两组将被随机分配接受光凝治疗 治疗组和对照组。 P 组和 I 组的患者将 其次是自然历史以及以后可能进入 随机研究。 预计招募 240 名患者 N组； P 组 480 人，I 组 240 人。约 50% 这些患者中的 也将有资格参加 M 组。患者将 这项为期 5 年的研究的前 3 年招募了所有患者 将进行跟踪直至研究结束。 该研究是 旨在提供有关是否 光凝可有效预防新生血管 中央静脉阻塞且视网膜非正常的青光眼 灌注，以及光凝是否有用 保持中央静脉阻塞眼睛的视力 黄斑水肿。 在基线和每次收集的信息 后续访问将转发给协调中心 处理和分析。 照片将在 阅读中心确定其资格和充分性 治疗。 数据监测委员会将审查临时 每 6 个月公布一次研究结果。