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

University of Utah16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Interventions

Early disclosureBEHAVIORAL

Late disclosureBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Twelve months

Data from ClinicalTrials.gov

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