MACULAR PHOTOCOAGULATION STUDY READING CENTER

黄斑光凝研究阅读中心

• 批准号: 3559150
• 负责人: NEIL M BRESSLER
• 金额: $ 55.95万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1993-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559150
• 关键词: aging; angiogenesis; clinical trials; disease /disorder prevention /control; eye fundus photography; eye laser surgery; eye surgery; fluorescein angiography; fovea centralis retinae; human subject; human therapy evaluation; medical complication; patient /disease registry; photocoagulation therapy; retina degeneration

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.

本提案适用于中央凹眼底照片阅读中心 光凝研究（FPS）。 这项多中心随机对照 拟开展临床试验评估氪红激光疗效 光凝治疗可预防严重视力丧失 患有年龄相关性黄斑变性 (AMD) 和黄斑中心凹的患者 新生血管病变。 AMD 是造成无法纠正的损失的主要原因 美国 60 岁及以上人群的视力。 鉴于 有证据表明光凝术对 75% 至 90% 的严重视力障碍有效 AMD 损失，提出一项前瞻性随机试验是合理的 氪激光光凝治疗黄斑中心凹下新生血管 膜。 两个患者组将分别进行评估：首先是从未有过的眼睛 治疗时存在离散的中心凹下新生血管膜，并且， 其次，最初接受中心凹外或中心凹旁膜治疗的眼睛 表现为中央凹中心下的复发。 一个注册表 对于其他符合条件但视力敏锐的患者将予以保留 太好了，无法满足资格要求。 目的 登记有两个作用：作为未来合格患者的来源； 记录 AMD 视力丧失的自然史。 预计将招募约 700 名患者 为期两年，每个研究组各一半，并进行至少 两年。 大约 100 名患者将在自然环境中接受随访 历史记录。 阅读中心将审查所有眼底照片和荧光素 参与研究的患者的血管造影在十二个临床 中心用于以下目的： 1. 确保选择参加 FPS 的患者符合资格 标准。 2. 确保光凝治疗按照 治疗方案。 3. 确定与治疗相关的并发症。 4. 描述眼睛中出现的病理情况，达到既定点 治疗过和未治疗过的眼睛。