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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00784225 |
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 |
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Prostate Cancer |
Drug: selenium Drug: vitamin E Procedure: medical chart review Procedure: questionnaire administration |
Study Type: | Observational |
Official Title: | Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE) |
Estimated Enrollment: | 2970 |
Study Start Date: | July 2004 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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]).
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Cataract or a cataract extraction at follow-up
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000617778, SWOG-S0000B |
Study First Received: | October 31, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00784225 |
Health Authority: | Unspecified |
prostate cancer |
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 |
Neoplasms Antioxidants Neoplasms by Site Molecular Mechanisms of Pharmacological Action Vitamins Growth Substances |
Physiological Effects of Drugs Trace Elements Micronutrients Protective Agents Pharmacologic Actions |