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The Roche European American Cataract Trial (REACT): A randomized clinical trial to investigate the efficacy of an oral antioxidant micronutrient mixture to slow progression of age-related cataract

2002; Taylor & Francis; Volume: 9; Issue: 1 Linguagem: Inglês

10.1076/opep.9.1.49.1717

1744-5086

The REACT Group, Leo T. Chylack, Nicholas Brown, Anthony J. Bron, Mark Hurst, Wolfgang Köpcke, Uta Thien, Wolfgang Schalch,

Antioxidant Activity and Oxidative Stress

context Funding surgery worldwide for age-related cataract (ARC), a leading cause of blindness, is a huge economic burden. Non-surgical means of slowing ARC progression could benefit patients and reduce this burden. objective To determine if a mixture of oral antioxidant micronutrients [mg/day] (ß-carotene [18], vitamin C [750], and vitamin E [600]) would modify progression of ARC. design REACT was a multi-centered, prospective, double-masked, randomized, placebo-controlled, 3-year trial. setting Consecutive adult American and English outpatients with early ARC were recruited. patients Four-hundred-and-forty-five patients were eligible; 297 were randomized; 231 (78%) were followed for two years; 158 (53%) were followed for three years; 36 (12%) were followed for four years. Twelve patients died during the trial (9 on vitamins; 3 on placebo (p = 0.07)). There were no serious safety issues. intervention After a three-month placebo run-in, patients were randomized by clinical center to the vitamin or placebo groups and followed every four months. main outcome measure Cataract severity was documented with serial digital retroillumination imagery of the lens; progression was quantified by image analysis assessing increased area of opacity. This measure of area, 'increase % pixels opaque' (IPO), was the main outcome measure. results There were no statistically significant differences between the treatment groups at baseline. The characteristics of dropouts and the mean follow-up times by treatment group were the same. After two years of treatment, there was a small positive treatment effect in U.S. patients (p = 0.0001); after three years a positive effect was apparent (p = 0.048) in both the U.S. and the U.K. groups. The positive effect in the U.S. group was even greater after three years: (IPO = 0.389 (vitamin) vs. IPO = 2.517 (placebo); p = 0.0001). There was no statistically significant benefit of treatment in the U.K. group. In spite of nearly perfect randomization into treatment groups, the U.S. and U.K. cohorts differed significantly. conclusion Daily use of the afore-mentioned micronutrients for three years produced a small deceleration in progression of ARC.