Macular Pigment Measurements in Eye & Other Tissues
1 other identifier
interventional
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
May 4, 2026
April 1, 2026
15 years
January 11, 2017
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Carotenoid levels in the eye
all study procedures are generally completed in a single study visit
at enrollment
Carotenoid levels in the skin
all study procedures are generally completed in a single study visit
at enrollment
Secondary Outcomes (1)
Carotenoid levels in the blood
at enrollment
Study Arms (1)
Carotenoid measurements
OTHERSubjects are asked to have carotenoid levels measured in the eye, skin and/or blood.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)).
You may not qualify if:
- Patients under age 7 will not be eligible to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Bernstein, MD, PhD
University of Utah Moran Eye Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Ophthalmology/Visual Sciences
Study Record Dates
First Submitted
January 11, 2017
First Posted
January 16, 2017
Study Start
June 1, 2015
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share