Macular PigmentationNCT03022773
Macular Pigment Measurements in Eye & Other Tissues
A study testing Carotenoid measurements in people with Macular Pigmentation and Skin Pigment, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Pigmentation, Skin Pigment
- What is being tested?
- Carotenoid measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- Patients under age 7 will not be eligible to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132
About this study
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.
- Conditions
- Macular Pigmentation, Skin Pigment
- Being tested
- Carotenoid measurements
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid measurementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Carotenoid measurements | Other | Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood. Receives: Other: Carotenoid measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotenoid levels in the eye
all study procedures are generally completed in a single study visit
Measured: at enrollment
Carotenoid levels in the skin
all study procedures are generally completed in a single study visit
Measured: at enrollment
Secondary outcomes (1)
Carotenoid levels in the blood
all study procedures are generally completed in a single study visit
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular PigmentationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S. Bernstein, University of Utah
- Investigators
- Paul Bernstein, MD, PhD, Principal investigator, University of Utah Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022773
- Sponsor's protocol ID
- IRB # 80132
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2017
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Pigment Measurements in Eye & Other Tissues
- ClinicalTrials.gov ID
- NCT03022773
- Acronym / sponsor ID
- IRB # 80132
- Conditions
- Macular Pigmentation, Skin Pigment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotenoid measurements | Other | Other: Carotenoid measurementsSubjects are asked to have carotenoid levels measured in the eye, skin and/or blood. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)).
Key exclusion criteria (1 listed)
- Patients under age 7 will not be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotenoid measurementsCarotenoid 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. | Other | Carotenoid measurements |
Primary outcome
Carotenoid levels in the eye
Time frame: at enrollment
all study procedures are generally completed in a single study visit
Carotenoid levels in the skin
Time frame: at enrollment
all study procedures are generally completed in a single study visit
1 secondary outcome
Carotenoid levels in the blood
Time frame: at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Macular Pigmentation
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RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
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RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
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Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Bernstein, MD, PhD principal investigator
University of Utah Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotenoid measurements in people with Macular Pigmentation and Skin Pigment, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotenoid levels in the eye (time frame: at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.