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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05265624
Other study ID # 150093
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 3, 2022
Est. completion date August 30, 2024

Study information

Verified date May 2024
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 for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 76
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Participants must be between 18 and 64 years of age. - They must also be Caucasian as this genetic test is only validated in Caucasians. - They can have a positive family history of AMD but this is not necessary. Exclusion Criteria: - Personal history of AMD - Non Caucasian - Employee of the Moran or other eye care practice (likely to have more knowledge about AMD than a layperson) - Personal history of prior genetic testing for AMD risk - Anticipated cataract surgery in the upcoming year (can affect Macular Pigment measurement) - Major psychiatric disorder

Study Design


Intervention

Behavioral:
Early disclosure of genetic testing results
Early disclosure group receives results of genetic testing at Month 1
Late disclosure of genetic testing results
Late disclosure group receives results of genetic testing at Month 12

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Paul S. Bernstein

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in skin carotenoid status in response to genetic risk disclosure as measured by Reflectance Spectroscopy Reflectance Spectroscopy (RS) is measured by Veggie Meter Units. Possible scores range from 0 (no carotenoids detected) to greater than 500. Change = (Month 12 Score - Baseline Score). Baseline and Month 12
Primary Change in skin carotenoid status in response to genetic risk disclosure as measured by Resonance Raman Spectroscopy Resonance Raman Spectroscopy (RSS) is measured in Raman Units. Possible scores range from 0 (no carotenoids detected) to greater than 100,000. Change = (Month 12 Score - Baseline Score). Baseline and Month 12
Secondary Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Volume Macular Pigment Optical Volume (MPOV) is a unitless measure of the amount of carotenoids present in the macula. Possible scores range from 0 (no carotenoids detected) to greater than 50,000. Change = (Month 12 Score - Baseline Score). Baseline and Month 12
Secondary Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density Macular Pigment Optical Density (MPOD) is a unitless measure of the amount of carotenoids present in the macula. Possible scores range from 0 (no carotenoids detected) to greater than 1. Change = (Month 12 Score - Baseline Score). Baseline and Month 12
Secondary Chang in serum carotenoid status in response to genetic risk disclosure Serum carotenoid levels are measured in nanograms per milliliter (ng/mL). Possible scores range from 0 (no carotenoids detected) to greater than 1,000. Change = (Month 12 Score - Baseline Score). Baseline and Month 12
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