Macular Pigment Measurements in Eye & Other Tissues

Not Applicable

Recruiting

• Conditions: Skin Pigment; Macular Pigmentation
• Interventions: Other: Carotenoid measurements

• Registration Number: NCT03022773
• Lead Sponsor: University of Utah

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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)).

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Exclusion Criteria

• Patients under age 7 will not be eligible to participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carotenoid measurements	Carotenoid measurements	Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.

Primary Outcome Measures

Name	Time	Method
Carotenoid levels in the skin	at enrollment	all study procedures are generally completed in a single study visit
Carotenoid levels in the eye	at enrollment	all study procedures are generally completed in a single study visit

Secondary Outcome Measures

Name	Time	Method
Carotenoid levels in the blood	at enrollment	all study procedures are generally completed in a single study visit

Trial Locations

Locations (1)

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