Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Change in carotenoid levels in the skin
Study Overview
Brief Summary
The goals of this study are:
To assess the impact of genetic testing based on how it alters behaviors, to assess the utility of serum biomarker measurement in combination with genetic testing, to assess the utility of genetic counseling in personal analysis of risk for age-related macular degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal neovascularization (CNV).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary.
Exclusion Criteria
- •Individuals with a personal history of AMD are not eligible. Non-caucasian individuals are not eligible. Employees of the Moran Eye Center are not eligible.
- •Individuals with a personal history of previous AMD genetic risk testing are not eligible.
- •Individuals with a major psychiatric disorder
Outcomes
Primary Outcomes
Change in carotenoid levels in the skin
Time Frame: Twelve months
Carotenoid levels in the skin are measured non-invasively at baseline and again at 12 months. Carotenoid levels are a biomarker of fruit and vegetable intake.
Change in carotenoid levels in the eyes
Time Frame: Twelve months
Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.
Secondary Outcomes
No secondary outcomes reported
Investigators
Paul S. Bernstein
Professor, Ophthalmology/Visual Sciences
University of Utah