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.
