S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)
- 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
- To test whether vitamin E and/or selenium reduces the risk of advanced AMD in these
- 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Visually significant age-related macular degeneration (AMD)
Every 6 months
William Christen, ScD
Dana-Farber/Brigham and Women's Cancer Center
United States: Federal Government
|Harvard Medical School||Boston, Massachusetts 02115|