Age-Related Macular Degeneration, Choroidal Neovascularization, Genetic Counseling
Conditions
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).
Interventions
BEHAVIORALEarly disclosure
BEHAVIORALLate disclosure
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in carotenoid levels in the skin | 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 | Twelve months | Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months. |
Countries
United States
Outcome results
None listed