MACULAR PHOTOCOAGULATION STUDY READING CENTER

这个方案是为中央凹的眼底照片阅读中心设计的

This proposal is for the Fundus Photograph Reading Center for the Foveal Photocoagulation Study (FPS). This multicenter randomized controlled clinical trial is proposed to evaluate the efficacy of krypton red laser photocoagulation therapy in preventing severe visual acuity loss in patients with age-related macular degeneration (AMD) and subfoveal neovascular lesions. AMD is the major cause of uncorrectable loss of vision in the U.S. among individuals 60 years of age and older. Given the evidence that photocoagulation is useful for 75 to 90% of severe visual loss in AMD, it is reasonable to propose a prospective randomized trial of krypton laser photocoagulation treatment for subfoveal neovascular membranes. Two patient groups will be evaluated separately: first, eyes never before treated in which there is a discrete subfoveal noevascular membrane, and, second, eyes initially treated for extrafoveal or juxtafoveal membranes that present with recurrences under the center of the fovea. A registry will be maintained for patients otherwise eligible but whose visual acuity is too good to meet the eligibility requirements. The purpose of the registry is two fold: to serve as a source of future eligible patients and to document the natural history of visual acuity loss in AMD. It is anticipated that approximately 700 patients will be recruited over a two year period, half into each study group, and followed for a minimum of two years. Approximately 100 patients will be followed in the natural history registry. The Reading Center will review all fundus photographs and fluorescein angiograms of patients entered into the study at the twelve clinical centers for the following purposes: 1. To insure that patients selected for the FPS meet the eligibility criteria. 2. To insure that photocoagulation treatment is carried out according to the treatment protocol. 3. To determine complications associated with treatment. 4. To describe pathology present in eyes reaching defined points for both treated and not treated eyes.