Eye Disease in a Trial of Selenium and Vitamin E

描述（由申请人提供）：该申请寻求5年的资助，包括正在进行的硒和维生素E癌症预防试验（SELECT）中对年龄相关性黄斑变性（AMD）和白内障的研究。SELECT是一项随机双盲、安慰剂对照、2x2因子试验，研究硒和维生素E在前列腺癌一级预防中的作用。目标样本是32400名健康男性，白人男性年龄在55岁及以上，非裔美国男性年龄在50岁及以上。研究时间计划为12年，统一计计期为5年，根据随机化时间的不同，干预时间最少为7年，最多为12年。这项正在进行的试验提供了一个独特的机会，在抗氧化剂的大型试验中检查AMD和白内障，而成本只是单独试验的一小部分。拟议的眼科研究将采用既定的程序来收集医疗记录数据，以确认SELECT研究参与者在两年一次的诊所就诊中报告的黄斑变性和白内障。本研究收集的数据将补充年龄相关性眼病研究（AREDS）收集的数据，提供维生素E和硒对AMD和白内障的个体影响的重要信息，包括但不限于疾病发展的早期阶段。结合AREDS和其他正在进行的男性和女性试验的发现，这项研究将有助于确定抗氧化维生素在预防不同风险水平的年龄相关性眼病方面的利弊平衡，从而为眼科保健提供者和患者提供更具体的临床建议。

DESCRIPTION (provided by applicant): This application seeks 5 years of funding to include a study of age-related macular degeneration (AMD) and cataract in the ongoing Selenium and Vitamin E Cancer Prevention Trial (SELECT). SELECT is a randomized double-blind, placebo-controlled, 2x2 factorial trial of selenium and vitamin E in the primary prevention of prostate cancer. The target sample is 32,400 healthy males, age 55 years and older for white men, and age 50 and older for African-American men. Study duration is planned to be 12 years with a 5-year uniform accrual period, and a minimum of 7 and maximum of 12 years of intervention depending on the time of randomization. This ongoing trial offers a unique opportunity to examine AMD and cataract in a large trial of antioxidants at a fraction of the cost of a separate trial. The proposed eye study will employ established procedures to collect medical record data to confirm reports of AMD and cataract made by SELECT study participants at bi-annual clinic visits. The data collected in this study will complement the data collected in the Age-Related Eye Disease Study (AREDS) by providing important information on the individual effects of vitamin E and selenium in AMD and cataract including, but not limited to, the earlier stages of disease development. Together with the findings in AREDS and in other ongoing trials in men and women, this study will help determine the balance of benefits and risks of antioxidant vitamins in the prevention of age-related eye disease in individuals at various levels of risk, and thus enable more specific clinical recommendations for eye health care providers and patients.