|Phase III||Natural history/Epidemiology||Active||55 and over (50 and over for African Americans)||NCI, Other||CDR0000617778|
S0000B, U10CA037429, R01EY014418, SWOG-S0000B, NCT00784225
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).
Further Study Information
- 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.
- 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]).
- 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 (Closed for accrual as of 10/01/29)
- 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
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- Not applicable
Trial Lead Organizations/Sponsors
Southwest Oncology GroupNational Cancer Institute
National Eye Institute
|William Christen||Study Chair|
|Dana Sparks, MAT||Ph: 210-614-8808 Ext.1004|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00784225
ClinicalTrials.gov processed this data on December 02, 2013
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