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Enrolling by invitationNCT03022773Updated May 4, 2026

Macular Pigment Measurements in Eye & Other Tissues

An interventional study of Carotenoid measurements in Macular Pigmentation and Skin Pigment, sponsored by University of Utah. Enrolling by invitation at 1 site in United States. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Utah · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jun 2015, registered Jan 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
10,000
Allocation
Not applicable
Ages
7 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Macular Pigmentation
  • Skin Pigment

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03

In context

Pigmentation Disorders

57 studies on the registry are indexed under Pigmentation Disorders; 12 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 35 across 44 interventional studies indexed under Pigmentation Disorders.

Browse Pigmentation Disorders studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Browse University of Utah studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients under age 7 will not be eligible to participate.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10,000 participants (estimated)

Study arms

  • Other
    Carotenoid measurements

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

    Other: Carotenoid measurements

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.

06

What researchers measure

Primary outcomes

  1. Carotenoid levels in the eye

    all study procedures are generally completed in a single study visit

    Time frame: at enrollment

  2. Carotenoid levels in the skin

    all study procedures are generally completed in a single study visit

    Time frame: at enrollment

Secondary outcomes

  1. Carotenoid levels in the blood

    all study procedures are generally completed in a single study visit

    Time frame: at enrollment

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2015 (actual). Primary completion is estimated for Jun 2030, 180 months after the start.

Of 21 interventional studies with no phase under Pigmentation Disorders, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 10. This study's planned 180 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2017
First posted
Jan 16, 2017
StartActual
Jun 2015
Primary completionEst.
Jun 2030
CompletionEst.
Jun 2030
Last update
May 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03022773
Lead sponsor
University of Utah
Responsible party
Paul S. Bernstein (Professor, Ophthalmology/Visual Sciences, University of Utah) — Principal investigator
First posted
Jan 16, 2017
Start date
Jun 2015
Primary completion
Jun 2030 (estimated)
Completion
Jun 2030 (estimated)
Last update
May 4, 2026

Study contacts

Paul Bernstein, MD, PhD
principal investigator · University of Utah Moran Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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