title: Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial.
abstract: OBJECTIVE
  Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention. However, the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium.
  
  
  OBJECTIVE
  To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men.
  
  
  METHODS
  The Selenium and Vitamin E Cancer Prevention Trial (SELECT) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT, a randomized placebo-controlled 4-arm trial of selenium and vitamin E conducted among 35,533 men, 50 years and older for African American participants and 55 years and older for all other men, at 427 participating sites in the United States, Canada, and Puerto Rico. A total of 11,267 SELECT participants from 128 SELECT sites participated in the SELECT Eye Endpoints ancillary study.
  
  
  METHODS
  Individual supplements of selenium (200 μg per day from L-selenomethionine) and vitamin E (400 IU per day of all rac-α-tocopheryl acetate).
  
  
  METHODS
  Incident cataract was defined as a lens opacity, age related in origin, and responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review. Cataract extraction was defined as the surgical removal of an incident cataract.
  
  
  RESULTS
  During a mean (SD) of 5.6 (1.2) years of treatment and follow-up, 389 cases of cataract were documented. There were 185 cataracts in the selenium group and 204 in the no selenium group (hazard ratio, 0.91; 95 % CI, 0.75-1.11; P = .37). For vitamin E, there were 197 cases in the treated group and 192 in the placebo group (hazard ratio, 1.02; 95 % CI, 0.84-1.25; P = .81). Similar results were observed for cataract extraction.
  
  
  CONCLUSIONS
  These data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00784225.
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: William G
authors.initials: WG
authors.lastname: Christen
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Glynn
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts2Division of Aging, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts3Vet.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Gaziano
authors.affiliation: Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Amy K
authors.initials: AK
authors.lastname: Darke
authors.affiliation: Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: John J
authors.initials: JJ
authors.lastname: Crowley
authors.affiliation: Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Phyllis J
authors.initials: PJ
authors.lastname: Goodman
authors.affiliation: Office of the Director, Moores Cancer Center, University of California at San Diego.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
authors.affiliation: Jesse Brown VA Medical Center, Chicago, Illinois.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Lad
authors.affiliation: Upstate Carolina Community Clinical Oncology Program/Spartanburg Regional Medical Center, Spartanburg, South Carolina.
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.affiliation: Medical Oncology, Swedish Medical Center, Seattle, Washington.
authors.forename: Gary E
authors.initials: GE
authors.lastname: Goodman
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.
authors.forename: Lori M
authors.initials: LM
authors.lastname: Minasian
authors.affiliation: Department of Urology, Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Thompson
authors.affiliation: Southwest Oncology Group Chair's Office, Knight Cancer Institute, Oregon Health and Sciences University, Portland.
authors.forename: Charles D
authors.initials: CD
authors.lastname: Blanke
authors.affiliation: Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Eric A
authors.initials: EA
authors.lastname: Klein
mesh_terms: D000368:Aged; D000375:Aging; D000975:Antioxidants / Q000008:administration & dosage*; D002386:Cataract / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D002387:Cataract Extraction / Q000706:statistics & numerical data*; D004311:Double-Blind Method; D004338:Drug Combinations; D023381:Endpoint Determination; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000517:prevention & control*; D012307:Risk Factors; D012645:Selenomethionine / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D014810:Vitamin E / Q000008:administration & dosage*
chemical_list: D000975:Antioxidants; D004338:Drug Combinations; D014810:Vitamin E; D012645:Selenomethionine