CENTRAL VEIN OCCLUSION STUDY-- PARTICIPATING CENTER

本申请是一个国家的参与中心 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到10个临床中心进行， 巴斯科姆帕尔默眼科研究所（巴斯科姆大学）的阅读中心 迈阿密）和斯科特和白色医院协调中心 Temple，Texas（Texas A&M University）德克萨斯A&M大学 患者将 分为四个研究组：非灌注组（N组），黄斑区组（B组）， 水肿（M组）、灌注（P组）和不确定（组 （一）。 前两组中的眼睛将被随机分配到 光凝治疗组或对照组。 患者 P组和I组的自然史和 可能以后进入随机化研究。 估计 N组招募240例患者，P组招募480例患者， 第一组。 这些患者中约有50%也符合资格 M组。 患者将在前三年招募 所有患者将接受随访，直至 研究终止。 该研究旨在提供 关于光凝是否 有效预防患眼的新生血管性青光眼， 中央静脉闭塞和视网膜无灌注，以及是否或 非光凝对保持眼睛视力有用 伴有中央静脉闭塞和黄斑水肿 信息 在基线时收集，每次随访访视将转发至 协调中心进行处理和分析。 照片 将在阅读中心进行审查，以确定是否合格， 充分的治疗。 数据监测委员会将 每六个月审查一次研究的中期结果。

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 eight to ten 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 indeterminate (Group I). Eyes in the first two groups will be randomly assigned to photocoagulation treatment or a control group. Patients in Groups P and I will be folllowed for natural history and for possible later entry into the randomized study. Estimated recruitment is 240 patients on 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 three years of this five-year study, and all patients will be followed until termination of the study. The study is designed to provide information regarding whether or not photocoagulatin is efficacious in preventing neovascular glaucoma in eyes with central vein occulsion and retinal nonperfusion, and whether or not photocoagulation in useful in preserving visual acuity in eyes with central vein occlusion and macular edema. Information collected at baseline and each followup 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 six months.