Macular Pigment Measurements in Eye & Other Tissues
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carotenoid measurements.
- Who it may be relevant to
- Registry conditions: Macular Pigmentation, Skin Pigment. Basic parameters: from 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Carotenoid levels in the eye [Time frame: at enrollment]
- Carotenoid levels in the skin [Time frame: at enrollment]
Secondary outcome measures (1)
- Carotenoid levels in the blood [Time frame: at enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Utah John A. Moran Eye Center — Salt Lake City
Identifiers
NCT: NCT03022773 · IRB # 80132