MACULAR PHOTOCOAGULATION STUDY READING CENTER

这份提案是为中心凹眼底照片阅读中心准备的 光凝研究(FPS)。这个多中心随机对照 建议进行临床试验以评估氪红激光的疗效 光凝治疗预防严重视力丧失的临床研究 老年性黄斑变性(AMD)和黄斑中心凹下患者 新生血管损伤。AMD是导致无法纠正的损失的主要原因 美国60岁及以上人群的视野。给定 有证据表明，光凝对75%至90%的严重视力有效 对于AMD的损失，建议进行一项前瞻性随机试验 氪激光光凝治疗中心凹下新生血管 膜。 将分别对两组患者进行评估：第一，从未见过的眼睛 治疗中有一层离散的中心凹下新生血管膜， 第二，最初治疗的眼球凹外膜或黄斑旁膜 在中心凹中心下方反复出现。注册表 将为符合其他条件但视力正常的患者提供 太好了，达不到资格要求。该计划的目的是 登记有两个方面：作为未来符合条件的患者的来源和 记录AMD患者视力下降的自然病史。 预计将在一年内招募大约700名患者 为期两年，每个研究组一半，然后至少 两年了。大约100名患者将在自然状态下接受随访 历史注册表。 阅读中心将审查所有眼底照片和荧光素 患者的血管造影术在12个临床期进入研究 中心用于以下目的： 1.确保获选参加新鲜粮食计划的病人符合资格 标准。 2.确保光凝治疗按规定进行 治疗方案。 3.确定与治疗相关的并发症。 4.描述眼睛到达两者的定义点时的病理 治疗过的眼睛和未治疗过的眼睛。

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.