COLLABORATIVE STUDY ON CENTRAL VEIN OCCLUSION

此申请是为国家阅读中心 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 将随访至研究终止。 这项研究是 旨在提供关于是否 光凝术可有效预防虹膜 眼内新生血管形成和随后的新生血管性青光眼 中央静脉阻塞和视网膜无灌注，以及是否 光凝或不光凝在保持视力方面是有用的， 中心静脉阻塞和黄斑水肿。 信息 在基线时收集，每次随访访视将转发 协调中心进行处理和分析。 拍摄照片以记录虹膜和视网膜的外观， 以及视网膜的荧光血管造影研究， 并转发给阅读中心进行分析和解读。 将患者纳入研究的各个组将 取决于对荧光血管造影片的解读 的 虹膜照片的解释将决定结果 可变虹膜新生血管。 A数据和安全性监测 委员会将每六个月审查一次研究的中期结果。 个月

This application is for a Reading 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 iris neovascularization and subsequent 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 taken to record the appearance of the iris and retina, as well as fluoresein angiographic studies of the retina will be forwarded to the Reading Center for analysis and interpretation. The inclusion of patients in the various groups in the study will depend upon the interpretation of the fluoresein angiogram. The interpretation of iris photographs will determine the outcome variable, iris neovascularization. A Data and Safety Monitoring Committee will review interim results of the study every six months.