Skip to content

Macular Pigment Measurements in Eye & Other Tissues

Macular Pigment Measurements in Eye & Other Tissues

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03022773
Enrollment
10000
Registered
2017-01-16
Start date
2015-06-01
Completion date
2030-06-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Pigmentation, Skin Pigment

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.

Interventions

OTHERCarotenoid 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.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Carotenoid levels in the eyeat enrollmentall study procedures are generally completed in a single study visit
Carotenoid levels in the skinat enrollmentall study procedures are generally completed in a single study visit

Secondary

MeasureTime frameDescription
Carotenoid levels in the bloodat enrollmentall study procedures are generally completed in a single study visit

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPaul Bernstein, MD, PhD

University of Utah Moran Eye Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026