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U. Chakravarthy, S. Beatty, M. Stevenson, The CARMA study group; Functional and Morphological Outcomes in the CARMA Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1257.
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To test the hypothesis that supplementation with Lutein (L) and Zeaxanthin (Z) and co-antioxidants (zinc, copper, vit. E and C) will result in improved functional and morphological outcomes relative to placebo (P) in patients at high risk of progression to late age-related macular degeneration
CARMA (Carotenoids and Co-antioxidants in Age-Related Maculopathy) is a randomised double masked prospective trial of L and Z with co-antioxidants (Active; A) versus placebo (P). A total of 433 participants were randomised to A or P in two centres Belfast and Waterford. Change in best corrected ETDRS distance visual acuity (BC DVA) at 4 meters was the primary outcome variable. At every study visit, fundus photographs were graded and serum L and Z and other antioxidants were measured. An analysis of covariance adjusted for baseline covariates was performed at 12 months. A general linear model was constructed to examine the longitudinal associations between BCDVA and serum L.
Mean change in BC DVA at 12 months was 0.007 in the P group and 0.002 in the A group but this difference while in favour of the A group was not statistically significant (p = 0.5). A ten-fold increase in serum L was associated with a 4-letter improvement of DVA (B -0.77, t -2.42, p = 0.017). A higher serum L was also associated with a slower rate of progression of AMD features (p = 0.011)
Although there was no difference in BC DVA at 12 months, oral supplementation with L and Z and co-antioxidants results in improved functional and morphological outcomes at 24 months in participants at high risk of progression to late AMD
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