SUBMACULAR SURGERY TRIALS--STUDY CHAIRMANS OFFICE GRANT

黄斑下手术试验——研究主席办公室拨款

• 批准号: 6032745
• 负责人: NEIL M BRESSLER
• 金额: $ 35.3万
• 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/6032745
• 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 评价手术切除中心凹下脉络膜新生血管 继发于年龄相关性黄斑变性的病变 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，眼组织胞浆菌病， 四项随机临床试验，每项针对不同的病变 类型和假定病因。每只眼睛仅一只（研究眼） 预计患者有资格接受四种SST中的一种 临床试验随机分配至对照组的患者 ARRN将通过观察（不治疗）或 激光光凝，取决于病变的类型， 早期治疗的临床试验结果 脉络膜新生血管每项的主要结果 试验将是研究眼的视力变化， 两年考试的基线， 视敏度在基线时被认为是成功的结果。的 主要次要结局将是健康相关 从基线到两年访谈的生活质量， 使用医学结局研究SF-36问卷进行评估。 其他特别关注的结果包括不良事件， 例如对研究眼的重复手术或其它治疗 和研究眼的可测量的视敏度的丧失。一 手术管理的平行经济分析将是 进行。 将对患者进行合格性评价、治疗， 在50至55岁时随访临床结果， 临床中心。其他SST中心将作为研究对象 董事长办公室，负责全面领导， SST的指导; SST协调中心，负责 科学领导和后勤保障， SST调查小组;和SST照片阅读中心， 负责评估眼科医生的能力 识别和招募合格患者，并遵守 治疗方案。SST将入组1600例患者 在两年的时间里， 符合条件的人员的试验治疗方案 SST协调中心独立的数据和安全性 监测委员会将审查数据，每次至少两次 评估手术的风险和益处。 此申请旨在资助 SST研究主席办公室。