COLLABORATIVE STUDY ON CENTRAL VEIN OCCLUSION

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(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 光凝对预防新生血管有效 中心静脉阻塞和视网膜非阻塞眼的青光眼 灌流，以及光凝术是否对 中央静脉阻塞合并黄斑变性患者的视力保护 黄斑水肿。在基线和每个基准线收集的信息 后续访问将转发至协调中心，以便 处理和分析。照片将在 阅读中心以确定以下内容的资格和充分性 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。

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.