<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022773</url>
  </required_header>
  <id_info>
    <org_study_id>IRB # 80132</org_study_id>
    <nct_id>NCT03022773</nct_id>
  </id_info>
  <brief_title>Macular Pigment Measurements in Eye &amp; Other Tissues</brief_title>
  <official_title>Macular Pigment Measurements in Eye &amp; Other Tissues</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand the role of nutrition and its effects on the eye&#xD;
      and other tissues. The investigators propose to study this by validating and correlating&#xD;
      various non-invasive measurement methods of carotenoid concentrations in the human eye and&#xD;
      skin tissue.&#xD;
&#xD;
      A secondary objective is to correlate blood levels of carotenoids on a sub-set of&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The macula of the human retina (the structure responsible for high acuity vision essential&#xD;
      for reading, driving and recognizing faces) is colored an intense yellow due to the&#xD;
      deposition of two carotenoid compounds, lutein and zeaxanthin. These xanthophyll carotenoids&#xD;
      are derived exclusively from the diet, and are hypothesized to protect the macula from&#xD;
      light-induced oxidative damage by virtue of their light-screening and antioxidant properties.&#xD;
&#xD;
      Epidemiological studies have shown that high dietary intake and blood levels of lutein and&#xD;
      zeaxanthin are associated with lower rates of vision loss due to age-related macular&#xD;
      degeneration (AMD).&#xD;
&#xD;
      It is of interest to correlate carotenoid levels in the eye and skin tissues with blood&#xD;
      levels of carotenoid compounds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Carotenoid levels in the eye</measure>
    <time_frame>at enrollment</time_frame>
    <description>all study procedures are generally completed in a single study visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carotenoid levels in the skin</measure>
    <time_frame>at enrollment</time_frame>
    <description>all study procedures are generally completed in a single study visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carotenoid levels in the blood</measure>
    <time_frame>at enrollment</time_frame>
    <description>all study procedures are generally completed in a single study visit</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Macular Pigmentation</condition>
  <condition>Skin Pigment</condition>
  <arm_group>
    <arm_group_label>Carotenoid measurements</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carotenoid measurements</intervention_name>
    <description>Carotenoid measurements of the eye (macula) are obtained through non-invasive ophthalmic photographs using the Heidelberg Spectralis imaging system.&#xD;
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.&#xD;
Carotenoid measurements in the blood are obtained through routine venipuncture.</description>
    <arm_group_label>Carotenoid measurements</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient age 7 or older, undergoing routine dilated ophthalmology examinations at&#xD;
             the Moran Eye Center will be eligible to participate.&#xD;
&#xD;
          -  Patients with adult vitelliform dystrophy. (This condition initially presents in&#xD;
             adulthood as bilateral subtle and often asymptomatic macular lesions, which are often&#xD;
             misdiagnosed as early age-related macular degeneration (AMD)).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under age 7 will not be eligible to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Bernstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Moran Eye Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul S. Bernstein, MD, PhD</last_name>
    <phone>801-581-4069</phone>
    <email>Paul.Bernstein@hsc.utah.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Utah John A. Moran Eye Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul S Bernstein, MD, PhD</last_name>
      <phone>801-581-4069</phone>
      <email>Paul.Bernstein@hsc.utah.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Paul S. Bernstein</investigator_full_name>
    <investigator_title>Professor, Ophthalmology/Visual Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pigmentation Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotenoids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022773
org study id: IRB # 80132
nct id: NCT03022773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Carotenoid levels in the eye
time frame: at enrollment
description: all study procedures are generally completed in a single study visit
measure: Carotenoid levels in the skin
time frame: at enrollment
description: all study procedures are generally completed in a single study visit
measure: Carotenoid levels in the blood
time frame: at enrollment
description: all study procedures are generally completed in a single study visit
arm group label: Carotenoid measurements
arm group type: Other
description: Subjects are asked to have carotenoid levels measured in the eye, skin and/or blood.
intervention type: Other
intervention name: Carotenoid measurements
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.
arm group label: Carotenoid measurements
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Bernstein, MD, PhD
role: Principal Investigator
affiliation: University of Utah Moran Eye Center
last name: Paul S. Bernstein, MD, PhD
phone: 801-581-4069
email: Paul.Bernstein@hsc.utah.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Paul S. Bernstein
investigator title: Professor, Ophthalmology/Visual Sciences
mesh term: Pigmentation Disorders
mesh term: Carotenoids
sharing ipd: No