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Macular Pigment Measurements in Eye & Other Tissues

Primary Purpose

Macular Pigmentation, Skin Pigment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carotenoid measurements
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Macular Pigmentation

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Utah John A. Moran Eye CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Carotenoid measurements

Arm Description

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

Outcomes

Primary Outcome Measures

Carotenoid levels in the eye
all study procedures are generally completed in a single study visit
Carotenoid levels in the skin
all study procedures are generally completed in a single study visit

Secondary Outcome Measures

Carotenoid levels in the blood
all study procedures are generally completed in a single study visit

Full Information

First Posted
January 11, 2017
Last Updated
May 3, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03022773
Brief Title
Macular Pigment Measurements in Eye & Other Tissues
Official Title
Macular Pigment Measurements in Eye & Other Tissues
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Pigmentation, Skin Pigment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carotenoid measurements
Arm Type
Other
Arm Description
Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.
Intervention Type
Other
Intervention Name(s)
Carotenoid measurements
Intervention Description
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 Outcome Measure Information:
Title
Carotenoid levels in the eye
Description
all study procedures are generally completed in a single study visit
Time Frame
at enrollment
Title
Carotenoid levels in the skin
Description
all study procedures are generally completed in a single study visit
Time Frame
at enrollment
Secondary Outcome Measure Information:
Title
Carotenoid levels in the blood
Description
all study procedures are generally completed in a single study visit
Time Frame
at enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul S. Bernstein, MD, PhD
Phone
801-581-4069
Email
Paul.Bernstein@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Bernstein, MD, PhD
Organizational Affiliation
University of Utah Moran Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul S Bernstein, MD, PhD
Phone
801-581-4069
Email
Paul.Bernstein@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Macular Pigment Measurements in Eye & Other Tissues

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