The Moran AMD Genetic Testing Assessment Study

Phase 2

Completed

• Conditions: Genetic Testing; Age-Related Macular Degeneration; Nutritional Biomarkers
• Interventions: Behavioral: Late disclosure of genetic testing results; Behavioral: Early disclosure of genetic testing results

• Registration Number: NCT05265624
• Lead Sponsor: Paul S. Bernstein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2022-08-03
• Primary Completion: 2024-07-12
• Study Completion: 2024-07-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late Genetic Results Disclosure	Late disclosure of genetic testing results	Late disclosure group receives results of genetic testing at Month 12
Early Genetic Results Disclosure	Early disclosure of genetic testing results	Early disclosure group receives results of genetic testing at Month 1

Primary Outcome Measures

Name	Time	Method
Change in skin carotenoid status in response to genetic risk disclosure as measured by Resonance Raman Spectroscopy	Baseline and Month 12	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).
Change in skin carotenoid status in response to genetic risk disclosure as measured by Reflectance Spectroscopy	Baseline and Month 12	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).

Secondary Outcome Measures

Name	Time	Method
Chang in serum carotenoid status in response to genetic risk disclosure	Baseline and Month 12	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).
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Volume	Baseline and Month 12	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).
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density	Baseline and Month 12	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).

Trial Locations

Locations (1)

University of Utah John A. Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States