CENTRAL VEIN OCCLUSION STUDY - PARTICIPATING CENTER

中央静脉闭塞研究 - 参与中心

• 批准号: 3559403
• 负责人: CLEMENT L TREMPE
• 金额: $ 13.65万
• 依托单位: SCHEPENS EYE RESEARCH INSTITUTE
• 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/3559403
• 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.

本申请是一个国家的参与中心 协作、随机、对照、临床试验， 中心静脉闭塞的光凝治疗。 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白色医院协调中心 德克萨斯A&M大学 患者将进入四项研究 组：非灌注组（N组），黄斑水肿组（M组）; 灌注组（P组）和不确定组（I组）。 眼睛在第一 将两组随机分配至光凝组 治疗组和对照组。 P组和I组的患者将 自然历史和可能的后来进入 随机研究。 预计招募240名患者， N组; P组480例，I组240例。 约50% 这些患者也将有资格进入M组。 患者将 在这项为期5年的研究的前3年招募，所有患者 将随访直至研究终止。 这项研究是 旨在提供关于是否 光凝可有效防止新生血管 青光眼合并中央静脉阻塞和视网膜非 灌注，以及光凝是否适用于 保留中央静脉阻塞眼的视力， 黄斑水肿 在基线收集的信息， 后续访问将转交协调中心， 处理和分析。 照片将在 阅读中心确定的资格和充分性 治疗 数据监测委员会将审查中期 研究结果每6个月。