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Macular Pigment Measurements in Eye & Other Tissues

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Invitation-only

Conditions

Skin Pigment
Macular Pigmentation

Treatments

Other: Carotenoid measurements

Study type

Interventional

Funder types

Other

Identifiers

NCT03022773
IRB # 80132

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

7+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10,000 participants in 1 patient group

Carotenoid measurements
Other group
Description:
Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.
Treatment:
Other: Carotenoid measurements

Trial contacts and locations

1

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Central trial contact

Paul S. Bernstein, MD, PhD

Data sourced from clinicaltrials.gov

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