Age Related Eye Disease Study 2 - Follow-on Study

年龄相关眼病研究 2 - 后续研究

• 批准号: 9175773
• 负责人: TRACI E CLEMONS
• 金额: $ 36.11万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-26 至 2016-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9175773
• 关键词: Ancillary Study; Archives; Ascorbic Acid; Authorization documentation; Back; Beta Carotene; Calendar; Cataract; Cataract Extraction; Certification; Cessation of life; Collaborations; Communication; Consent Forms; Consultations; Contractor; Contracts; Data; Data Analyses; Data Collection; Data Set; Databases; Diagnosis; Diagnostic; Disease; Documentation; Dose; Drug Formulations; Electronics; Enrollment; Ensure; Event; Eye diseases; Health; Health Insurance Portability and Accountability Act; Individual; Information Technology; Informed Consent; Life Style; Link; Lutein; Malignant Neoplasms; Malignant neoplasm of lung; Manuals; Medical; Medical Records; Methods; Modification; Monitor; Nutritional Study; Oral; Outcome; Paper; Participant; Pathology; Performance; Physicians; Policies; Press Releases; Procedures; Process; Protocols documentation; Publications; Randomized Controlled Clinical Trials; Recording of previous events; Reporting; Resources; Retinal; Risk; Safety; Schedule; Secure; Security; Services; Site; Slide; Source; Surveys; System; Telephone Interviews; Testing; Training; Translational Research; Update; Validation; Visit; Vitamins; Writing; Zinc; age related; aged; base; clinical research site; cohort; data management; electronic data; experience; follow-up; indexing; lens; meetings; mortality; randomized trial; therapy development; web site; zeaxanthin

AREDS2 is one of the longest and perhaps the largest randomized controlled clinical trial of lutein/zeaxanthin. The AREDS2 cohort provides valuable resources with which to assess safety and efficacy data on use of these compounds. A central focus will be on ocular- (retinal- and lens-based) and cancer-based endpoints. In 2009, Satia et al. reported an increased risk of lung cancer associated with long term lutein supplement use participants of the VITamins And Lifestyle (VITAL) Study aged 50 to 76 years.a As AREDS2 is a randomized controlled clinical trial, additional follow-up of study participants would permit us to determinate whether high-dose oral lutein supplement use increases risk of lung cancer. Information regarding mortality will be collected through telephone interviews and the National Death Index search. We will also use this opportunity to ask for the ocular outcomes by asking at the telephone interview for cataract surgery and treatment for AMD. Mortality is associated with ocular disease, specifically advanced AMD and cataract, as demonstrated by our previous randomized trial of the AREDS formulation (Vitamins C, E, beta-carotene, and zinc) for AMD and cataract.

AREDS 2是叶黄素/玉米黄质最长的，也许是最大的随机对照临床试验之一。AREDS 2队列提供了宝贵的资源，可用于评估这些化合物使用的安全性和有效性数据。中心焦点将集中在眼部（基于视网膜和晶状体）和基于癌症的终点。2009年，Satia等人报告了与长期服用叶黄素补充剂相关的肺癌风险增加，VITALs和生活方式（VITAL）研究的参与者年龄在50至76岁之间。由于AREDS 2是一项随机对照临床试验，对研究参与者进行额外随访将使我们能够确定高剂量口服叶黄素补充剂是否会增加肺癌风险。有关死亡率的信息将通过电话采访和国家死亡指数搜索收集。我们还将利用这个机会通过电话询问白内障手术和AMD治疗的眼部结果。正如我们之前针对AMD和白内障的AREDS制剂（维生素C、E、β-胡萝卜素和锌）随机试验所证明的那样，死亡率与眼部疾病相关，特别是晚期AMD和白内障。