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The Age-Related Eye Disease Study 2 (AREDS2) Research Team presented the results of the multi-centered randomized controlled clinical trial of oral supplementation with lutein/zeaxanthin (10 mg/2mg) and/or omega-3 long-chain polyunsaturated fatty acids (LCPUFAs-1 g) for the treatment of age-related macular degeneration (AMD) and cataract.
This multi-centered trial was conducted in 82 clinical sites in the U.S., in both academic and community-based centers with retinal specialists from 2006 to 2012, in 4,203 participants, aged 50 – 85. These nutritional supplements were added to the Age-Related Eye Disease Study (AREDS) formulation consisting of vitamins C, E, beta-carotene, zinc and copper. The AREDS2 participants consented to either take the original AREDS formulation or a randomly assigned variation of the AREDS formulation.
Participants had comprehensive ocular exams at annual study visits which included best-corrected visual acuity testing and ocular photography. The main outcome measurement was progression to advanced AMD, neovascular or central geographic atrophy determined by centralized fundus photographic grading with a standardized protocol and by history of treatment. Progression to cataract surgery and progression of lens opacity, determined by centralized ocular photography using red reflex photos with a standardized protocol, obtained at annual study visits, was a secondary outcome.