title: Lutein/zeaxanthin for the treatment of age-related cataract: AREDS2 randomized trial report no. 4.
abstract: OBJECTIVE
  Age-related cataract is a leading cause of visual impairment in the United States. The prevalence of age-related cataract is increasing, with an estimated 30.1 million Americans likely to be affected by 2020.
  
  
  OBJECTIVE
  To determine whether daily oral supplementation with lutein/zeaxanthin affects the risk for cataract surgery.
  
  
  METHODS
  The Age-Related Eye Disease Study 2 (AREDS2), a multicenter, double-masked clinical trial, enrolled 4203 participants, aged 50 to 85 years, at risk for progression to advanced age-related macular degeneration.
  
  
  METHODS
  Participants were randomly assigned to daily placebo; lutein/zeaxanthin, 10mg/2mg; omega-3 long-chain polyunsaturated fatty acids, 1 g; or a combination to evaluate the effects on the primary outcome of progression to advanced age-related macular degeneration.
  
  
  METHODS
  Cataract surgery was documented at annual study examination with the presence of pseudophakia or aphakia, or reported during telephone calls at 6-month intervals between study visits. Annual best-corrected visual acuity testing was performed. A secondary outcome of AREDS2 was to evaluate the effects of lutein/zeaxanthin on the subsequent need for cataract surgery.
  
  
  RESULTS
  A total of 3159 AREDS2 participants were phakic in at least 1 eye and 1389 of 6027 study eyes underwent cataract surgery during the study, with median follow-up of 4.7 years. The 5-year probability of progression to cataract surgery in the no lutein/zeaxanthin group was 24%. For lutein/zeaxanthin vs no lutein/zeaxanthin, the hazard ratios for progression to cataract surgery was 0.96 (95% CI, 0.84-1.10; P = .54). For participants in the lowest quintile of dietary intake of lutein/zeaxanthin, the hazard ratio comparing lutein/zeaxanthin vs no lutein/zeaxanthin for progression to cataract surgery was 0.68 (95% CI, 0.48-0.96; P = .03). The hazard ratio for 3 or more lines of vision loss was 1.03 (95% CI, 0.93-1.13; P = .61 for lutein/zeaxanthin vs no lutein/zeaxanthin).
  
  
  CONCLUSIONS
  Daily supplementation with lutein/zeaxanthin had no statistically significant overall effect on rates of cataract surgery or vision loss.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00345176.
authors: National Eye Institute/National Institutes of Health, Bethesda, MD 20892, USA.
authors: Emily Y
authors: EY
authors: Chew
authors: John Paul
authors: JP
authors: SanGiovanni
authors: Frederick L
authors: FL
authors: Ferris
authors: Wai T
authors: WT
authors: Wong
authors: Elvira
authors: E
authors: Agron
authors: Traci E
authors: TE
authors: Clemons
authors: Robert
authors: R
authors: Sperduto
authors: Ronald
authors: R
authors: Danis
authors: Suresh R
authors: SR
authors: Chandra
authors: Barbara A
authors: BA
authors: Blodi
authors: Amitha
authors: A
authors: Domalpally
authors: Michael J
authors: MJ
authors: Elman
authors: Andrew N
authors: AN
authors: Antoszyk
authors: Alan J
authors: AJ
authors: Ruby
authors: David
authors: D
authors: Orth
authors: Susan B
authors: SB
authors: Bressler
authors: Gary E
authors: GE
authors: Fish
authors: George B
authors: GB
authors: Hubbard
authors: Michael L
authors: ML
authors: Klein
authors: Thomas R
authors: TR
authors: Friberg
authors: Philip J
authors: PJ
authors: Rosenfeld
authors: Cynthia A
authors: CA
authors: Toth
authors: Paul
authors: P
authors: Bernstein
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D002386:Cataract / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D002387:Cataract Extraction / Q000706:statistics & numerical data*; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use; D005260:Female; D006801:Humans; D014975:Lutein / Q000097:blood / Q000627:therapeutic use*; D008297:Male; D014786:Vision Disorders / Q000175:diagnosis; D014792:Visual Acuity; D024341:Xanthophylls / Q000097:blood / Q000627:therapeutic use*; D065146:Zeaxanthins
chemical_list: D015525:Fatty Acids, Omega-3; D024341:Xanthophylls; D065146:Zeaxanthins; D014975:Lutein
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