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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03024424
Other study ID # IRB 60413
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date August 10, 2017

Study information

Verified date May 2023
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 10, 2017
Est. primary completion date August 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Early disclosure

Late disclosure


Locations

Country Name City State
United States University of Utah John A. Moran Eye Center Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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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