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.

候选人在临床眼科和眼部流行病学方面具有背景，并提议将其对眼病的工作和预防扩展到预防白内障领域。该应用程序概述了白内障相关临床试验中的三相培训计划。在第一阶段，将在约翰·霍普金斯公共卫生学院的临床试验中心进行临床试验理论的课堂培训。生物统计学和流行病学课程将为其余的培训提供理论框架。第二阶段将涉及与年龄相关的眼病研究的主持下的临床试验中的实践培训。 （AREDS）。 AREDS是一项随机，受控的临床试验，旨在以前瞻性探索抗氧化剂和其他因素对与年龄相关性白内障的进展的影响。该候选人将在一项计划中由研究主席Frederick Ferris博士进行监督，该计划将包括参加AREDS研究运营委员会的月度会议，以及贝塞斯达（Bethesda）的数据监测委员会和AREDS技术小组的年度会议，参与质量控制场地访问和协调中心的其他活动以及研究数据的其他活动。在培训的最后阶段，候选人将设计和执行一项临床试验，这是对中国Linxian白内障试验的后续审判。这些是第一个随机对照试验，证明补充抗氧化剂可能会阻碍白内障的进展。拟议的研究将利用国家癌症中心与癌症相关事件研究所（National Cancer Center Center for Cancer Chance Chistitute for Cancer Chance Chastitute for Cancer Chance Chistute for Cancer Chance Chistute for Cancer Chance Cassitute for Cancer Charting）的持续检查，该队列现年55岁及以上，以获取有关15年来抗氧化剂治疗对镜头不透明度的长期影响的独特信息。这项研究将利用候选人在书面和口语中的流利程度。希拉·韦斯特（Sheila West）博士将通过培训的三个阶段提供整体指导。