CENTRAL VEIN OCCLUSION STUDY

此申请是为国家协调中心 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9个临床中心进行，阅读 巴斯科姆帕尔默眼科研究所中心（迈阿密大学） 斯科特和白色医院的协调中心 Temple，Texas（Texas A&M University）. 患者将进入 分为四个研究组：非灌注（N组）;黄斑水肿 （M组）;灌注（P组）;和不确定（I组）。 眼睛 将被随机分配到 光凝治疗组和对照组。 患者 P组和I组将被随访自然史和可能的 随后进入随机化研究。 预计征聘人数为 792例患者：N组238例; P组396例和 I. 这些患者中约有一半也将在M组。 患者 将在五年研究的前三年招募 所有患者将被随访三年或直到 研究终止。 该研究旨在提供 关于光凝是否 有效预防新血管形成和随后的 中央静脉阻塞眼的新生血管性青光眼， 视网膜缺血和光凝治疗是否 可用于保留CVO和黄斑病变患者的视力 水肿 基线和每次随访访视时收集的信息 将转交协调中心处理， 分析. 数据监测委员会将审查中期 每六个月公布一次研究结果。

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.