Macular Pigment Measurements in Eye & Other Tissues

Skin Pigment Clinical Trial

Official title:

Macular Pigment Measurements in Eye & Other Tissues

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03022773
• Other study ID #: IRB # 80132
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: Paul S. Bernstein, MD, PhD
• Phone: 801-581-4069
• Email: Paul.Bernstein[@]hsc.utah.edu
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Macular Pigmentation
• Pigmentation Disorders
• Skin Pigment

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