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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03022773
Other study ID # IRB # 80132
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date June 2025

Study information

Verified date May 2024
Source University of Utah
Contact Paul S. Bernstein, MD, PhD
Phone 801-581-4069
Email Paul.Bernstein@hsc.utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to understand the role of nutrition and its effects on the eye and other tissues. The investigators propose to study this by validating and correlating various non-invasive measurement methods of carotenoid concentrations in the human eye and skin tissue. A secondary objective is to correlate blood levels of carotenoids on a sub-set of participants.


Description:

The macula of the human retina (the structure responsible for high acuity vision essential for reading, driving and recognizing faces) is colored an intense yellow due to the deposition of two carotenoid compounds, lutein and zeaxanthin. These xanthophyll carotenoids are derived exclusively from the diet, and are hypothesized to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties. Epidemiological studies have shown that high dietary intake and blood levels of lutein and zeaxanthin are associated with lower rates of vision loss due to age-related macular degeneration (AMD). It is of interest to correlate carotenoid levels in the eye and skin tissues with blood levels of carotenoid compounds.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years and older
Eligibility Inclusion Criteria: - Any patient age 7 or older, undergoing routine dilated ophthalmology examinations at the Moran Eye Center will be eligible to participate. - Patients with adult vitelliform dystrophy. (This condition initially presents in adulthood as bilateral subtle and often asymptomatic macular lesions, which are often misdiagnosed as early age-related macular degeneration (AMD)). Exclusion Criteria: - Patients under age 7 will not be eligible to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Carotenoid measurements
Carotenoid measurements of the eye (macula) are obtained through non-invasive ophthalmic photographs using the Heidelberg Spectralis imaging system. Carotenoid measurements of the skin are measured by a laboratory instrument that uses a painless blue laser light for exposure of the skin and a photodetector for scattered light. Carotenoid measurements in the blood are obtained through routine venipuncture.

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 Carotenoid levels in the eye all study procedures are generally completed in a single study visit at enrollment
Primary Carotenoid levels in the skin all study procedures are generally completed in a single study visit at enrollment
Secondary Carotenoid levels in the blood all study procedures are generally completed in a single study visit at enrollment
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