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A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation with Vitamins C and E and Beta Carotene for Age-Related Cataract and Vision Loss: AREDS Report No. 9


Journal Article

AREDS), A.R.Eye Diseas

Arch Ophthalmol




Aged; aging; Antioxidants; Ascorbic Acid; Beta Carotene; cataract; Dietary Supplements; Disease Progression; Double-Blind Method; Female; Lens- Crystalline; Male; Middle Aged; Odds Ratio; Photography; Risk Factors; Vision Disorders; visual acuity

{BACKGROUND: Experimental and observational data suggest that micronutrients with antioxidant capabilities may retard the development of age-related cataract. OBJECTIVE: To evaluate the effect of a high-dose antioxidant formulation on the development and progression of age-related lens opacities and visual acuity loss. DESIGN: The 11-center Age-Related Eye Disease Study (AREDS) was a double-masked clinical trial. Participants were randomly assigned to receive daily oral tablets containing either antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg) or no antioxidants. Participants with more than a few small drusen were also randomly assigned to receive tablets with or without zinc (80 mg of zinc as zinc oxide) and copper (2 mg of copper as cupric oxide) as part of the age-related macular degeneration trial. Baseline and annual (starting at year 2) lens photographs were graded at a reading center for the severity of lens opacities using the AREDS cataract grading scale. MAIN OUTCOME MEASURES: Primary outcomes were (1) an increase from baseline in nuclear, cortical, or posterior subcapsular opacity grades or cataract surgery, and (2) at least moderate visual acuity loss from baseline (>/=15 letters). Primary analyses used repeated-measures logistic regression with a statistical significance level of P =.01. Serum level measurements, medical histories, and mortality rates were used for safety monitoring. RESULTS: Of 4757 participants enrolled, 4629 who were aged from 55 to 80 years had at least 1 natural lens present and were followed up for an average of 6.3 years. No statistically significant effect of the antioxidant formulation was seen on the development or progression of age-related lens opacities (odds ratio = 0.97

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