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Clinical Trials/NCT03024424
NCT03024424CompletedNot Applicable

Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

University of Utah2 sites in 1 country16 target enrollmentStarted: March 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paul S. Bernstein

Professor, Ophthalmology/Visual Sciences

University of Utah

Study Sites (2)

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