<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/NCT02223546</url>
  </required_header>
  <id_info>
    <org_study_id>CVdi</org_study_id>
    <nct_id>NCT02223546</nct_id>
  </id_info>
  <brief_title>Circadian Macular Volume Changes in the Choroid</brief_title>
  <acronym>CVdi</acronym>
  <official_title>Pilotstudy: Diurnal Changes in Choroidal Volume</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Choroidal volume measured fluctuates significantly over a 24 hour time frame.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg&#xD;
      Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be&#xD;
      performed in both eyes after pupil dilation.&#xD;
&#xD;
      Scanning Protocol: This studies choroidal volume measurement protocol has been previously&#xD;
      published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a&#xD;
      single investigator. To optimize image quality each B-scan will be averaged from at least 25&#xD;
      individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering,&#xD;
      Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a&#xD;
      30x25 degree area around the fovea.&#xD;
&#xD;
      Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at&#xD;
      0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure&#xD;
      measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will&#xD;
      be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for&#xD;
      examination at 0 and 3.&#xD;
&#xD;
      OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for&#xD;
      automated choroidal volume calculation by the devices build in software. Choroidal thickness&#xD;
      is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and&#xD;
      the hyper reflective layer behind the large vessels of the choroid (chorio-scleral&#xD;
      interface). The devices Software thus generates a three-dimensional choroidal thickness map,&#xD;
      divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition&#xD;
      to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated&#xD;
      caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.&#xD;
&#xD;
      This is considered a pilot study, so explorative data analysis will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Macular Choroidal Volume</measure>
    <time_frame>daily average out of measurements every 3 hours within a 24 hour timeframe</time_frame>
    <description>macular choroidal volume in the central 6mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subfoveal Choroidal Thickness</measure>
    <time_frame>daily average out of measurements every 3 hours within a 24 hour timeframe</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean Ocular Perfusion Pressure</measure>
    <time_frame>every 3 hours within a 24 hour timeframe</time_frame>
    <description>mean arterial pressure (MAP) is defined as DBP + 1/3(SBP - DBP); mean ocular perfusion pressure results from 2/3(MAP - IOP).</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Choroid Physiology</condition>
  <arm_group>
    <arm_group_label>healthy subject</arm_group_label>
    <description>healthy subject, every 3 hour measurement</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Helathy human subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-65, signed informed consent form,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any ocular pathology, including history of ocular surgery or trauma, use of ocular&#xD;
             medication, elevated intraocular pressure (IOP), or significant vitreous floaters.&#xD;
             Further exclusion criteria were current use of any systemic medications, history of&#xD;
             cardio-vascular disease, diabetes mellitus, or hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerald Seidel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology, Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/25447108</url>
    <description>PMID 25447108</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>July 21, 2020</results_first_submitted>
  <results_first_submitted_qc>September 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2020</results_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Healthy Subject</title>
          <description>healthy subject, every 3 hour measurement</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Subject</title>
          <description>healthy subject, every 3 hour measurement</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Macular Choroidal Volume</title>
        <description>macular choroidal volume in the central 6mm</description>
        <time_frame>daily average out of measurements every 3 hours within a 24 hour timeframe</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Subject</title>
            <description>healthy subject, every 3 hour measurement</description>
          </group>
        </group_list>
        <measure>
          <title>Macular Choroidal Volume</title>
          <description>macular choroidal volume in the central 6mm</description>
          <units>mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.33" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subfoveal Choroidal Thickness</title>
        <time_frame>daily average out of measurements every 3 hours within a 24 hour timeframe</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Subject</title>
            <description>healthy subject, every 3 hour measurement</description>
          </group>
        </group_list>
        <measure>
          <title>Subfoveal Choroidal Thickness</title>
          <units>µm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="378.1" spread="111.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Ocular Perfusion Pressure</title>
        <description>mean arterial pressure (MAP) is defined as DBP + 1/3(SBP - DBP); mean ocular perfusion pressure results from 2/3(MAP - IOP).</description>
        <time_frame>every 3 hours within a 24 hour timeframe</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Healthy Subject</title>
          <description>healthy subject, every 3 hour measurement</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gerald Seidel, MD</name_or_title>
      <organization>Medical University of Graz</organization>
      <phone>+43 316 385 12394</phone>
      <email>gerald.seidel@medunigraz.at</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02223546
org study id: CVdi
nct id: NCT02223546
lead sponsor: 
has dmc: No
Choroidal volume measured fluctuates significantly over a 24 hour time frame.
All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg
      Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be
      performed in both eyes after pupil dilation.

      Scanning Protocol: This studies choroidal volume measurement protocol has been previously
      published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a
      single investigator. To optimize image quality each B-scan will be averaged from at least 25
      individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering,
      Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a
      30x25 degree area around the fovea.

      Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at
      0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure
      measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will
      be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for
      examination at 0 and 3.

      OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for
      automated choroidal volume calculation by the devices build in software. Choroidal thickness
      is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and
      the hyper reflective layer behind the large vessels of the choroid (chorio-scleral
      interface). The devices Software thus generates a three-dimensional choroidal thickness map,
      divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition
      to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated
      caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.

      This is considered a pilot study, so explorative data analysis will be performed.
observational model: Other
time perspective: Prospective
measure: Macular Choroidal Volume
time frame: daily average out of measurements every 3 hours within a 24 hour timeframe
description: macular choroidal volume in the central 6mm
measure: Subfoveal Choroidal Thickness
time frame: daily average out of measurements every 3 hours within a 24 hour timeframe
measure: Mean Ocular Perfusion Pressure
time frame: every 3 hours within a 24 hour timeframe
description: mean arterial pressure (MAP) is defined as DBP + 1/3(SBP - DBP); mean ocular perfusion pressure results from 2/3(MAP - IOP).
arm group label: healthy subject
description: healthy subject, every 3 hour measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerald Seidel, MD
role: Principal Investigator
affiliation: Medical University of Graz
facility: 
country: Austria
url: https://www.ncbi.nlm.nih.gov/pubmed/25447108
description: PMID 25447108
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 