CLINICAL TRIALS IN CATARACT PREVENTION

白内障预防的临床试验

• 批准号: 6178721
• 负责人: NATHAN G CONGDON
• 金额: $ 18.3万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6178721
• 关键词: antioxidants; ascorbate; cataract; clinical research; clinical trials; diet therapy; disease /disorder prevention /control; experimental designs; eye disorder diagnosis; human subject; longitudinal human study; nutrition related tag; pathologic process; questionnaires; retinoids; solar radiation; tocopherols; vitamin therapy

The candidate has a background in clinical ophthalmology and ocular epidemiology, and proposes to extend his work and prevention of eye disease into the field of cataract prevention. This application outlines a three-phase training program in cataract-related clinical trials. In the first phase, class classroom training in the theory of clinical trials will be undertaken at the Center for Clinical Trials of the Johns Hopkins School of Public Health under Dr. Curtis Meinert. Courses in Biostatistics and Epidemiology will provide a theoretical framework for the remainder of the training. The second phase will involve practical training in clinical trials under the auspices of the Age-Related Eye Disease Study. (AREDS). AREDS is a randomized, controlled clinical trial designed to explore in prospective fashion the impact of anti-oxidants and other factors on the progression of age-related cataract. The candidate will be supervised by the Study Chairman, Dr. Frederick Ferris, in a program that will include participation in monthly meetings of the AREDS Study Operations Committee and annual meetings of the Data Monitoring Committee and AREDS Technical Group in Bethesda, participation in Quality Control Site Visits and other activities of the Coordinating Center, and analysis of study data. In the final phase of training, the candidate will design and execute a clinical trial, a follow-up on the Linxian Cataract Trials in China. These were the first randomized, controlled trials to demonstrate that supplementation with anti-oxidants could retard progression of cataract. The proposed study will take advantage of continued examination of this cohort, now aged 55 years and above, by the National Cancer Center Institute for cancer-related events, to obtain unique information on the long-term effects of anti-oxidant treatment on lens opacity over 15 years. This study will exploit the candidate's fluency in written and spoken Chinese. Dr. Sheila West will provide overall direction through the three phases of training.

该候选人具有临床眼科和眼流行病学背景，并提议将其工作和眼病预防扩展到白内障预防领域。该申请概述了白内障相关临床试验的三阶段培训计划。在第一阶段，临床试验理论的课堂培训将在约翰·霍普金斯大学公共卫生学院临床试验中心由 Curtis Meinert 博士进行。生物统计学和流行病学课程将为其余培训提供理论框架。第二阶段将包括在与年龄相关的眼病研究的支持下进行临床试验的实践培训。 （阿雷兹）。 AREDS 是一项随机对照临床试验，旨在前瞻性地探讨抗氧化剂和其他因素对年龄相关性白内障进展的影响。候选人将接受研究主席 Frederick Ferris 博士的监督，参与一项计划，其中包括参加 AREDS 研究运营委员会的月度会议以及在贝塞斯达举行的数据监测委员会和 AREDS 技术小组的年度会议，参与质量控制协调中心的实地考察和其他活动，以及研究数据分析。在培训的最后阶段，候选人将设计并执行一项临床试验，这是中国临县白内障试验的后续行动。这些是第一个证明补充抗氧化剂可以延缓白内障进展的随机对照试验。拟议的研究将利用国家癌症中心癌症相关事件研究所对这一年龄在 55 岁及以上的队列的持续检查，以获得抗氧化治疗对晶状体混浊的长期影响的独特信息超过15年。这项研究将利用候选人的中文书面和口语流利程度。 Sheila West 博士将通过三个阶段的培训提供总体指导。