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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early disclosure | Experimental | Early disclosure group receives results of genetic testing at Week 4 |
|
| Late disclosure | Active Comparator | Late disclosure group receives results of genetic testing at final study visit (Month 12) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early disclosure | Behavioral |
| ||
| Late disclosure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in carotenoid levels in the skin | 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. | Twelve months |
| Change in carotenoid levels in the eyes | Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months. | Twelve months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S. Bernstein, MD, PhD | University of Utah Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah John A. Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
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Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
|
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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