MACULAR PHOTOCOAGULATION STUDY READING CENTER

黄斑光凝研究阅读中心

• 批准号: 3559151
• 负责人: NEIL M BRESSLER
• 金额: $ 58.29万
• 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 1994-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559151
• 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.

本提案是为中央凹眼底照片阅读中心 光凝研究（FPS）。 本多中心随机对照 建议进行临床试验以评价氪红激光的疗效 光凝治疗预防严重视力丧失 年龄相关性黄斑变性（AMD）和中心凹下 新生血管病变 AMD是不可纠正的损失的主要原因 在美国，60岁及以上的人的视力。 鉴于 有证据表明，光凝术对75%至90%的严重视力 在AMD的损失，是合理的，提出一个前瞻性随机试验， 氪激光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：第一，以前从未见过的眼睛 其中存在离散的中央凹下新生血管膜，并且， 第二，最初治疗中心凹外膜或中心凹旁膜的眼睛 在中央凹下呈复发性。 注册表 对于其他条件合格但视力 太好了，不符合资格要求。 的目的 登记有两个方面：作为未来合格患者的来源， 以记录AMD中视力丧失的自然史。 预计将招募约700名患者， 为期两年，每个研究组一半，并随访至少 两年 大约100名患者将在自然条件下接受随访。 历史记录 阅读中心将审查所有眼底照片和荧光素 在12个临床试验中进入研究的患者的血管造影照片 用于以下目的的中心： 1.确保入选FPS的患者符合资格 的搜索. 2.为了确保根据以下要求进行光凝治疗， 治疗方案。 3.确定与治疗相关的并发症。 4.描述达到规定点的眼睛中存在的病理学， 治疗和未治疗的眼睛。