COLLABORATIVE STUDY ON CENTRAL VEIN OCCLUSION

这是一个全国性的阅读中心的申请表 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)，以及 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)。患者将进入四项研究 组：非灌注组(N组)、黄斑水肿组(M组)； 灌流组(P组)和不确定组(I组)。眼睛在第一眼 两组将被随机分配到光凝组 治疗组和对照组。P组和I组的患者将 接下来是自然历史和后来可能进入的 随机研究。据估计，在中国招募240名患者 N组；P组480人，I组240人。约50% 这些患者中也将有资格进入M组。 在这项为期5年的研究的前3年招募，所有患者 将被跟踪，直到研究结束。这项研究是 旨在提供有关是否 光凝是预防虹膜的有效方法 眼部新生血管与继发性新生血管性青光眼 中心静脉阻塞和视网膜无灌注，以及 无论光凝术对保持视力是否有用 有中心静脉阻塞和黄斑水肿的眼。信息 在基线收集和每次后续访问将被转发 送到协调中心处理和分析。 用来记录虹膜和视网膜外观的照片， 以及对视网膜的荧光素血管造影研究将是 转发给阅读中心进行分析和解读。 将患者纳入研究的不同群体将 取决于荧光素血管造影的解释。这个 对虹膜照片的解读将决定结果 可变的，虹膜新生血管。A数据与安全监测 委员会将每六年审查一次中期研究结果 月份。

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.