CENTRAL VEIN OCCLUSION STUDY-- PARTICIPATING CENTER

此申请是针对国家队的一名参赛中锋 联合随机对照临床试验 中心静脉闭塞的光凝治疗。这项研究 将在8到10个临床中心进行， 巴斯科姆·帕尔默眼科研究所阅读中心 迈阿密)和斯科特和怀特医院的协调中心 在德克萨斯州坦普尔(德克萨斯A&M大学)。病人将会是 分为四组：非灌注组(N组)、黄斑组 水肿组(M组)、灌注组(P组)和不确定组(组 i)。前两组的眼睛将被随机分配到 光凝治疗组或对照组。入院的病人 P组和I组的自然历史和 有可能在以后进入随机研究。估计 N组240人，P组480人，240人 在第一组中，大约50%的患者也将符合条件 对于M组，患者将在头三年招募 在这项为期五年的研究中，所有患者都将接受跟踪，直到 终止研究。这项研究旨在提供 关于光凝是否为 青光眼预防新生血管性青光眼疗效观察 中心静脉闭塞与视网膜无血流灌注 光凝不能有效地保护眼睛的视力 伴有中央静脉阻塞和黄斑水肿。信息 在基线收集，并将每次后续访问转发到 处理和分析的协调中心。照片 将在阅读中心进行审查，以确定资格和 治疗是否充分。一个数据监测委员会将 每六个月审查一次研究的中期结果。

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 eight to ten 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: nonperfused (Group N), macular edema (Group M), perfused (Group P), and indeterminate (Group I). Eyes in the first two groups will be randomly assigned to photocoagulation treatment or a control group. Patients in Groups P and I will be folllowed for natural history and for possible later entry into the randomized study. Estimated recruitment is 240 patients on 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 three years of this five-year study, and all patients will be followed until termination of the study. The study is designed to provide information regarding whether or not photocoagulatin is efficacious in preventing neovascular glaucoma in eyes with central vein occulsion and retinal nonperfusion, and whether or not photocoagulation in useful in preserving visual acuity in eyes with central vein occlusion and macular edema. Information collected at baseline and each followup 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 six months.