<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/NCT03821467</url>
  </required_header>
  <id_info>
    <org_study_id>OPHT-010418</org_study_id>
    <nct_id>NCT03821467</nct_id>
  </id_info>
  <brief_title>Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects</brief_title>
  <official_title>Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dual beam Doppler Fourier-domain Optical coherence tomography (DOCT) is a noninvasive&#xD;
      technique to quantify total retinal blood flow.&#xD;
&#xD;
      To enable further development of this technique it is essential to assess short- and&#xD;
      long-term reproducibility of DOCT blood flow measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, total retinal blood flow will be measured with DOCT at multiple time&#xD;
      points to gain information of short- and long-term reproducibility. In addition, provocation&#xD;
      with flickering light will be performed, which is known to lead to vasodilatation and an&#xD;
      increase in retinal blood flow in healthy subjects. Vessel diameters will also be measured&#xD;
      using the Dynamic Vessel Analyzer (DVA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">December 12, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 12, 2023</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>Retinal blood-flow variation over time</measure>
    <time_frame>14 +/- 3 days</time_frame>
    <description>as measured using DOCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Flicker induced blood flow alterations</measure>
    <time_frame>14 +/- 3 days</time_frame>
    <description>as measured using DOCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flicker induced vasodilatation and hyperemia</measure>
    <time_frame>14 +/- 3 days</time_frame>
    <description>as measured using DOCT and DVA</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Ocular Blood Flow</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual beam Doppler Fourier-domain OCT (DOCT)</intervention_name>
    <description>Retinal blood flow will be assessed using DOCT.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic Vessel Analyzer (DVA)</intervention_name>
    <description>Retinal vessel diameters and oxygen saturation will be measured with the DVA device.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical coherence tomography (OCT)</intervention_name>
    <description>Retinal morphology will be imaged using OCT.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 18 and 35 years&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Normal findings in the medical history unless the investigator considers an&#xD;
             abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Normal ophthalmic findings, ametropy &lt; 3 Dpt.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular use of medication, abuse of alcoholic beverages, participation in a clinical&#xD;
             trial in the 3 weeks preceding the study&#xD;
&#xD;
          -  Treatment in the previous 3 weeks with any drug (except contraceptives)&#xD;
&#xD;
          -  Symptoms of a clinically relevant illness in the 3 weeks before the first study day&#xD;
&#xD;
          -  Blood donation during the previous 3 weeks&#xD;
&#xD;
          -  Pregnancy, planned pregnancy or lactating&#xD;
&#xD;
          -  History or family history of epilepsia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doreen Schmidl, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna, Department of Clinical Pharmacology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Doreen Schmidl, MD, PhD</last_name>
    <phone>0043140400</phone>
    <phone_ext>29810</phone_ext>
    <email>klin-pharmakologie@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Vienna, Department of Clinical Pharmacology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Doreen Schmidl, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Doreen Schmidl, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>https://klpharm.meduniwien.ac.at/</url>
    <description>Medical University of Vienna, Department of Clinical Pharmacology</description>
  </link>
  <reference>
    <citation>Werkmeister RM, Dragostinoff N, Palkovits S, Told R, Boltz A, Leitgeb RA, Groschl M, Garhofer G, Schmetterer L. Measurement of absolute blood flow velocity and blood flow in the human retina by dual-beam bidirectional Doppler fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Sep 12;53(10):6062-71. doi: 10.1167/iovs.12-9514.</citation>
    <PMID>22893675</PMID>
  </reference>
  <reference>
    <citation>Doblhoff-Dier V, Schmetterer L, Vilser W, Garhofer G, Groschl M, Leitgeb RA, Werkmeister RM. Measurement of the total retinal blood flow using dual beam Fourier-domain Doppler optical coherence tomography with orthogonal detection planes. Biomed Opt Express. 2014 Jan 28;5(2):630-42. doi: 10.1364/BOE.5.000630. eCollection 2014 Feb 1.</citation>
    <PMID>24575355</PMID>
  </reference>
  <reference>
    <citation>Werkmeister RM, Palkovits S, Told R, Groschl M, Leitgeb RA, Garhofer G, Schmetterer L. Response of retinal blood flow to systemic hyperoxia as measured with dual-beam bidirectional Doppler Fourier-domain optical coherence tomography. PLoS One. 2012;7(9):e45876. doi: 10.1371/journal.pone.0045876. Epub 2012 Sep 18.</citation>
    <PMID>23029289</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Doreen Schmidl</investigator_full_name>
    <investigator_title>Associate Professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>doppler optical coherence tomography</keyword>
  <keyword>dynamic vessel analyzer</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03821467
org study id: OPHT-010418
nct id: NCT03821467
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dual beam Doppler Fourier-domain Optical coherence tomography (DOCT) is a noninvasive
      technique to quantify total retinal blood flow.

      To enable further development of this technique it is essential to assess short- and
      long-term reproducibility of DOCT blood flow measurements.
In the present study, total retinal blood flow will be measured with DOCT at multiple time
      points to gain information of short- and long-term reproducibility. In addition, provocation
      with flickering light will be performed, which is known to lead to vasodilatation and an
      increase in retinal blood flow in healthy subjects. Vessel diameters will also be measured
      using the Dynamic Vessel Analyzer (DVA).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Retinal blood-flow variation over time
time frame: 14 +/- 3 days
description: as measured using DOCT
measure: Flicker induced blood flow alterations
time frame: 14 +/- 3 days
description: as measured using DOCT
measure: Flicker induced vasodilatation and hyperemia
time frame: 14 +/- 3 days
description: as measured using DOCT and DVA
arm group label: Healthy subjects
arm group type: Experimental
description: Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)
intervention type: Device
intervention name: Dual beam Doppler Fourier-domain OCT (DOCT)
description: Retinal blood flow will be assessed using DOCT.
arm group label: Healthy subjects
intervention type: Device
intervention name: Dynamic Vessel Analyzer (DVA)
description: Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
arm group label: Healthy subjects
intervention type: Device
intervention name: Optical coherence tomography (OCT)
description: Retinal morphology will be imaged using OCT.
arm group label: Healthy subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Doreen Schmidl, MD, PhD
role: Principal Investigator
affiliation: Medical University of Vienna, Department of Clinical Pharmacology
last name: Doreen Schmidl, MD, PhD
phone: 0043140400
phone ext: 29810
email: klin-pharmakologie@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
investigator: 
country: Austria
url: https://klpharm.meduniwien.ac.at/
description: Medical University of Vienna, Department of Clinical Pharmacology
citation: Werkmeister RM, Dragostinoff N, Palkovits S, Told R, Boltz A, Leitgeb RA, Groschl M, Garhofer G, Schmetterer L. Measurement of absolute blood flow velocity and blood flow in the human retina by dual-beam bidirectional Doppler fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Sep 12;53(10):6062-71. doi: 10.1167/iovs.12-9514.
PMID: 22893675
citation: Doblhoff-Dier V, Schmetterer L, Vilser W, Garhofer G, Groschl M, Leitgeb RA, Werkmeister RM. Measurement of the total retinal blood flow using dual beam Fourier-domain Doppler optical coherence tomography with orthogonal detection planes. Biomed Opt Express. 2014 Jan 28;5(2):630-42. doi: 10.1364/BOE.5.000630. eCollection 2014 Feb 1.
PMID: 24575355
citation: Werkmeister RM, Palkovits S, Told R, Groschl M, Leitgeb RA, Garhofer G, Schmetterer L. Response of retinal blood flow to systemic hyperoxia as measured with dual-beam bidirectional Doppler Fourier-domain optical coherence tomography. PLoS One. 2012;7(9):e45876. doi: 10.1371/journal.pone.0045876. Epub 2012 Sep 18.
PMID: 23029289
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Doreen Schmidl
investigator title: Associate Professor, MD, PhD
sharing ipd: Undecided