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OpenTrials
Enrolling by Invitation

NCT Number: NCT03022773

Macular Pigment Measurements in Eye & Other Tissues

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.

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Key information

Conditions

Macular Pigmentation Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin Pigment Skin and Connective Tissue Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotenoid measurements

Other

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.

Primary outcomes

  1. Carotenoid levels in the eye

    Time frame: at enrollment

    all study procedures are generally completed in a single study visit

  2. Carotenoid levels in the skin

    Time frame: at enrollment

    all study procedures are generally completed in a single study visit

Secondary outcomes

  1. Carotenoid levels in the blood

    Time frame: at enrollment

    all study procedures are generally completed in a single study visit

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Jan 16, 2017
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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