title: Secondary outcomes in a clinical trial of carotenoids with coantioxidants versus placebo in early age-related macular degeneration.
abstract: OBJECTIVE
  To report the secondary outcomes in the Carotenoids with Coantioxidants in Age-Related Maculopathy trial.
  
  
  METHODS
  Randomized double-masked placebo-controlled clinical trial (registered as ISRCTN 94557601).
  
  
  METHODS
  Participants included 433 adults 55 years of age or older with early age-related macular degeneration (AMD) in 1 eye and late-stage disease in the fellow eye (group 1) or early AMD in both eyes (group 2).
  
  
  METHODS
  An oral preparation containing lutein (L), zeaxanthin (Z), vitamin C, vitamin E, copper, and zinc or placebo. Best-corrected visual acuity (BCVA), contrast sensitivity (CS), Raman spectroscopy, stereoscopic colour fundus photography, and serum sampling were performed every 6 months with a minimum follow-up time of 12 months.
  
  
  METHODS
  Secondary outcomes included differences in BCVA (at 24 and 36 months), CS, Raman counts, serum antioxidant levels, and progression along the AMD severity scale (at 12, 24, and 36 months).
  
  
  RESULTS
  The differential between active and placebo groups increased steadily, with average BCVA in the former being approximately 4.8 letters better than the latter for those who had 36 months of follow-up, and this difference was statistically significant (P = 0.04). In the longitudinal analysis, for a 1-log-unit increase in serum L, visual acuity was better by 1.4 letters (95% confidence interval, 0.3-2.5; P = 0.01), and a slower progression along a morphologic severity scale (P = 0.014) was observed.
  
  
  CONCLUSIONS
  Functional and morphologic benefits were observed in key secondary outcomes after supplementation with L, Z, and coantioxidants in persons with early AMD.
authors.affiliation: Macular Pigment Research Group, Waterford Institute of Technology, Waterford City, Waterford, Republic of Ireland.
authors.forename: Stephen
authors.initials: S
authors.lastname: Beatty
authors.affiliation: Center for Vascular and Vision Sciences, Institute of Clinical Science, The Royal Victoria Hospital, Belfast, Northern Ireland. Electronic address: u.chakravarthy@qub.ac.uk.
authors.forename: Usha
authors.initials: U
authors.lastname: Chakravarthy
authors.affiliation: Macular Pigment Research Group, Waterford Institute of Technology, Waterford City, Waterford, Republic of Ireland.
authors.forename: John M
authors.initials: JM
authors.lastname: Nolan
authors.affiliation: Centre for Public Health, Queen's University of Belfast, Northern Ireland.
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Muldrew
authors.affiliation: Centre for Public Health, Queen's University of Belfast, Northern Ireland.
authors.forename: Jayne V
authors.initials: JV
authors.lastname: Woodside
authors.affiliation: Exploristics, Forsyth House, Cromac Square Belfast, Northern Ireland.
authors.forename: Frances
authors.initials: F
authors.lastname: Denny
authors.affiliation: Centre for Public Health, Queen's University of Belfast, Northern Ireland.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Stevenson
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000097:blood / Q000627:therapeutic use; D015350:Contrast Sensitivity / Q000502:physiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005470:Fluorometry; D006801:Humans; D014975:Lutein / Q000097:blood / Q000627:therapeutic use*; D008268:Macular Degeneration / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D013058:Mass Spectrometry; D008875:Middle Aged; D013059:Spectrum Analysis, Raman; D013607:Tablets; D014131:Trace Elements / Q000627:therapeutic use; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014810:Vitamin E / Q000097:blood / Q000627:therapeutic use; D024341:Xanthophylls / Q000097:blood / Q000627:therapeutic use*; D065146:Zeaxanthins
chemical_list: D000975:Antioxidants; D013607:Tablets; D014131:Trace Elements; D024341:Xanthophylls; D065146:Zeaxanthins; D014810:Vitamin E; D001205:Ascorbic Acid; D014975:Lutein