CENTRAL VEIN OCCLUSION STUDY-- PARTICIPATING CENTER

此申请是针对某国家的参与中心

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.