Macular Pigment Measurements in Eye & Other Tissues

Sponsor
University of Utah (Other)
Overall Status
Recruiting
CT.gov ID
NCT03022773
Collaborator
(none)
10,000
1
1
120
83.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Carotenoid measurements
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Macular Pigment Measurements in Eye & Other Tissues
Actual Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Carotenoid measurements

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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Carotenoid levels in the eye [at enrollment]

    all study procedures are generally completed in a single study visit

  2. Carotenoid levels in the skin [at enrollment]

    all study procedures are generally completed in a single study visit

Secondary Outcome Measures

  1. Carotenoid levels in the blood [at enrollment]

    all study procedures are generally completed in a single study visit

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Utah John A. Moran Eye Center Salt Lake City Utah United States 84132

Sponsors and Collaborators

  • University of Utah

Investigators

  • Principal Investigator: Paul Bernstein, MD, PhD, University of Utah Moran Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul S. Bernstein, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier:
NCT03022773
Other Study ID Numbers:
  • IRB # 80132
First Posted:
Jan 16, 2017
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021