S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - 120
Updated:6/30/2018
Start Date:July 2004
End Date:May 2018

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S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

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).

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]).

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 (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

PATIENT CHARACTERISTICS:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:
We found this trial at
1
site
Boston, Massachusetts 02115
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Boston, MA
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