S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
Condition: Cataract; Macular Degeneration
MeSH terms: Cataract; Macular Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent
      cataracts or age-related macular degeneration in men receiving these drugs as part of a
      clinical trial 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 men enrolled on SELECT
      (SWOG-S0000).
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To test whether vitamin E and/or selenium reduces the risk of visually significant
           age-related macular degeneration (AMD) in men enrolled on SELECT (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]).
    

Intervention name(s): selenium; vitamin E; vitamin E placebo; selenium placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mcg daily for 7-12 years; 400 IU daily by mouth for 7-12 years; daily for 7-12 years; daily for 7-12 years
Other intervention name(s): L-selenomethionine; alpha tocopherol; placebo; placebo
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cataract; advanced macular degeneration