Macular Pigment Measurements in Eye & Other Tissues

NCT ID: NCT03022773

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2030-06-30

Brief Summary

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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

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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.

Conditions

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Macular Pigmentation Skin Pigment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Carotenoid measurements

Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.

Group Type OTHER

Carotenoid measurements

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Paul S. Bernstein

Professor, Ophthalmology/Visual Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Bernstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Moran Eye Center

Locations

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University of Utah John A. Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB # 80132

Identifier Type: -

Identifier Source: org_study_id

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