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Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Older Men Enrolled on SELECT Clinical Trial SWOG-S0000
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00784225
  Purpose

RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in older men receiving these drugs for the prevention of prostate cancer.

PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in older men enrolled on SELECT clinical trial SWOG-S0000.


Condition Intervention
Prostate Cancer
Drug: selenium
Drug: vitamin E
Procedure: medical chart review
Procedure: questionnaire administration

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Cancer Cataract Macular Degeneration Prostate Cancer
Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Selenium
U.S. FDA Resources
Study Type: Observational
Official Title: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Visually significant age-related macular degeneration (AMD) [ Designated as safety issue: No ]
  • Visually significant cataract [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Advanced AMD (evidence of geographic atrophy or exudative disease) [ Designated as safety issue: No ]
  • Total AMD (with or without vision loss) [ Designated as safety issue: No ]
  • Surgical removal of an incident cataract or subtype [ Designated as safety issue: No ]

Estimated Enrollment: 2970
Study Start Date: July 2004
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To test whether vitamin E and/or selenium reduces the risk of visually significant age-related macular degeneration (AMD) in older men enrolled on SELECT clinical trial SWOG-S0000.
  • To test whether vitamin E and/or selenium reduces the risk of cataract in these participants.

Secondary

  • To test whether vitamin E and/or selenium reduces the risk of advanced AMD in these participants.
  • To test whether vitamin E and/or selenium reduces the risk of cataract surgery and subtypes in these participants.

OUTLINE: This is a multicenter study.

Data from medical records obtained from the participant's ophthalmologist or optometrist are reviewed. Information from these records is then used to confirm baseline reports of age-related macular degeneration (AMD) as well as 6-month and annual reports of new diagnoses of AMD and cataract (or cataract surgery) made since the start of this study. Detailed questionnaires are also obtained from the participant's ophthalmologist or optometrist to provide information about the reported AMD or cataract diagnosis (e.g., date of initial diagnosis; best-corrected visual acuity at the time of diagnosis; date when visual acuity was first noted to be 20/30 or worse [if different from the date of initial diagnosis]; pathological findings observed when AMD was first diagnosed [e.g., drusen, retinal pigment epithelial hypo/hyperpigmentation, geographic atrophy, retinal pigment epithelial detachment, subretinal neovascular membrane, or disciform scar]; pathological findings observed when visual acuity was first noted to be 20/30 or worse; date when exudative [wet] AMD was first noted; presence of other ocular abnormalities that could explain or contribute to visual loss; whether AMD or cataract, by itself, are significant enough to cause vision to be reduced to 20/30 or worse; whether laser treatment or photodynamic therapy was performed for AMD; date of cataract extraction; etiology of cataract [e.g., age-related, traumatic, congenital, inflammatory, or surgery- or steroid-induced]; and cataract type [e.g., nuclear, cortical, posterior subcapsular, or other]).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000
  • Diagnosis of 1 of the following:

    • Age-related macular degeneration (AMD) at baseline or at follow-up
    • Cataract or a cataract extraction at follow-up

      • Participants with a prior diagnosis of cataract at baseline followed by another cataract event (cataract diagnosis or a cataract extraction) at follow-up are not eligible
      • Participants with a prior diagnosis of cataract at baseline followed by a diagnosis of AMD at follow-up are eligible

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784225

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: William Christen, ScD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000617778, SWOG-S0000B
Study First Received: October 31, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00784225  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
prostate cancer

Study placed in the following topic categories:
Tocopherol acetate
Genital Neoplasms, Male
Prostatic Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Urogenital Neoplasms
Genital Diseases, Male
Alpha-Tocopherol
Tocopherols
Selenium
Vitamin E
Cataract
Prostatic Neoplasms
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Neoplasms
Antioxidants
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Vitamins
Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009