SUBMACULAR SURGERY TRIALS--STUDY CHAIRMAN'S OFFICE GRANT

黄斑下手术试验——研究主席办公室拨款

• 批准号: 2656146
• 负责人: NEIL M BRESSLER
• 金额: $ 75.9万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2656146
• 关键词: aging; clinical research; clinical trials; cooperative study; eye fundus photography; eye surgery; functional ability; histoplasmosis; human subject; human therapy evaluation; longitudinal human study; macular degeneration; macular drusen; pathologic process; photocoagulation therapy; postoperative complications; quality of life; relapse /recurrence; uvea disorder; visual perception

The purpose of the Submacular Surgery Trials (SST) is to evaluate surgical removal of subfoveal choroidal neovascular lesions secondary to age-related macular degeneration, which is the most prevalent cause of irreversible severe vision loss in Americans over 65, ocular histoplasmosis, and unknown causes in four randomized clinical trials, each for a different lesion type and presumed etiology. Only one eye (study eye) of each patient is expected to be eligible for one of the four SST clinical trials. Patients assigned at random to the control arrn will be managed by either observation (no treatment) or laser photocoagulation, depending upon the type of lesion and the findings from earlier clinical trials of treatment of choroidal neovascularization. The primary outcome for each trial will be change in visual acuity of the study eye from baseline to the two-year examination, with better or same visual acuity as at baseline deemed a successfitl outcome. The principal secondary outcome will be change in health-related quality of life from baseline to the two-year interview, as assessed using the Medical Outcomes Study SF-36 questionnaire. Other outcomes of particular interest include adverse events, such as repeated surgery or other treatment of the study eye and loss of measurable visual acuity in the study eye. A parallel economic analysis of surgical management will be undertaken. Patients will be evaluated for eligibility, treated, and followed for clinical outcomes at 50 to 55 collaborating clinical centers. Other SST centers will be the Study Chairman's Office, responsible for overall leadership and direction of the SST; the SST Coordinating Center, responsible for providing scientific leadership and logistic support to the SST investigative team; and the SST Photograph Reading Center, responsible for assessing the ability of the ophthalmologists to identify and enroll eligible patients and to adhere to the treatment protocol. 1600 patients will be enrolled in the SST in a two-year period and randomly assigned to one of the two treatment arrns of the trial for which eligible by personnel at the SST Coordinating Center. An independent Data and Safety Monitoring Committee will review the data at least twice each year to assess the risks and benefits of surgery. This application is for funding to support the activities of the SST Study Chairman's Office.

黄斑下手术试验(SST)的目的是 黄斑中心凹下脉络膜新生血管的手术切除 继发于老年性黄斑变性的损害 不可逆转的严重视力丧失的最常见原因是 65岁以上的美国人患有眼组织胞浆菌病，原因不明 四项随机临床试验，每项针对不同的病变 类型和推定病因学。每只眼睛只有一只(学习用的眼睛) 患者将有资格获得四种SST中的一种 临床试验。随机分配到对照组的患者 ARRN将通过观察(不治疗)或 激光光凝，取决于病变的类型和 早期临床试验的治疗结果 脉络膜新生血管。每一项的主要结果 试验将改变研究眼的视力从 两年制考试的基准线，好坏不一 视力在基线时被认为是成功的结果。这个 主要次要结果将是与健康相关的变化 从基线到两年面谈的生活质量，如 使用医疗结果研究SF-36问卷进行评估。 其他特别令人感兴趣的结果包括不良事件， 例如重复手术或学习眼的其他治疗 以及学习眼的可测量视力的丧失。一个 手术管理的并行经济分析将是 承担了。 将对患者进行资格评估、治疗和 在50到55岁的合作时间内跟踪临床结果 临床中心。其他SST中心将成为研究对象 主席办公室，负责全面领导和 SST方向；SST协调中心，负责 提供科学的领导和后勤支持 SST调查组和SST图片阅读中心， 负责评估眼科医生的能力 识别和登记符合条件的患者，并遵守 治疗方案。将有1600名患者参加SST 在两年内随机分配给两个人中的一个 有资格参加试验的人员的治疗报告 SST协调中心。独立的数据与安全 监测委员会将对数据进行至少两次审查 每年评估手术的风险和好处。 本申请书是为资助下列活动而提出的申请 SST研究主席办公室。