CENTRAL VEIN OCCLUSION STUDY -- COORDINATION CENTER

此申请表是针对某国家协调中心的 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 将在九个临床中心进行，阅读 巴斯科姆·帕尔默眼科研究所(迈阿密大学)中心 以及斯科特和怀特医院的协调中心 德克萨斯州坦普尔(德克萨斯农工大学)。患者将被录入 分为四组：非灌注组(N组)；黄斑水肿 (M组)；灌流组(P组)；以及不确定组(I组)。眼睛 在前两组将被随机分配到 光凝治疗组和对照组。入院的病人 P组和I组将在自然历史和可能的情况下 随后进入随机研究。预计招聘人数为 792例患者：N组238例，P组396例，P组158例 I.这些患者中约有一半也将属于M组患者 将在这五年学习的前三年招募 所有患者都将接受为期三年或直到 终止研究。这项研究旨在提供 关于是否光凝的信息 有效预防新生血管及随后的血管形成 中心静脉阻塞的新生血管性青光眼 视网膜缺血与光凝治疗的关系 对患CVO和黄斑病变的眼保持视力有帮助 浮肿。在基线和每次后续访问时收集的信息 将被转发到协调中心进行处理和 分析。数据监测委员会将审查临时 每六个月一次的研究结果。

This application is for the Coordinating Center of a national collaborative randomized controlled clinical trial of photocoagulation treatment for central vein occlusion. The study will be conducted in nine 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 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. Projected recruitment is 792 patients: 238 in in Group N; 396 in Group P and 158 in Group I. About half of these patients will also be in Group M. Patients will be recruited for the first three years of this five year study and all patients will be followed for three years or until termination of the study. The study is designed to provide information regarding whether or not photocoagulation is efficacious in preventing neovascularization and subsequent neovascular glaucoma in eyes with central vein occlusion and retinal ischemia and whether or not photocoagulation treatment is useful in preserving visual acuity in eyes with CVO and macular edema. Information collected at baseline and each follow-up visit will be forwarded to the Coordinating Center for processing and analysis. A data monitoring committee will review interim results of the study every six months.