<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/NCT01732042</url>
  </required_header>
  <id_info>
    <org_study_id>USB-2011-326</org_study_id>
    <nct_id>NCT01732042</nct_id>
  </id_info>
  <brief_title>Retinal Venous Pressure (RVP) in Normals</brief_title>
  <official_title>Retinal Venous Pressure (RVP) in Normals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determinate the standard values of the retinal venous pressure in a cohort of healthy&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The retinal venous pressure (RVP) is an increasingly important dimension in the clinical&#xD;
      assessment of retinal blood flow.&#xD;
&#xD;
      In literature only very few and also divergent data on the retinal venous pressure in healthy&#xD;
      volunteers are described. A normal value study will provide us with an up-to-date database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal venous pressure</measure>
    <time_frame>1 hour</time_frame>
    <description>Quantification of the retinal venous pressure as a standard value in a cohort of healthy volunteers</description>
  </primary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Healthy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  eye diseases&#xD;
&#xD;
          -  systemic diseases&#xD;
&#xD;
          -  term medication (except contraceptives)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  allergies to the ingredients Alcaine, Tropicamide and Phenylephrine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josef Flammer, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Basel, Dept. of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Basel, Dept. of Ophthalmology</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>December 10, 2013</last_update_submitted>
  <last_update_submitted_qc>December 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>retinal venous pressure</keyword>
  <!-- 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/NCT01732042
org study id: USB-2011-326
nct id: NCT01732042
lead sponsor: 
has dmc: No
Determinate the standard values of the retinal venous pressure in a cohort of healthy
      subjects.
The retinal venous pressure (RVP) is an increasingly important dimension in the clinical
      assessment of retinal blood flow.

      In literature only very few and also divergent data on the retinal venous pressure in healthy
      volunteers are described. A normal value study will provide us with an up-to-date database.
observational model: Cohort
time perspective: Prospective
measure: Retinal venous pressure
time frame: 1 hour
description: Quantification of the retinal venous pressure as a standard value in a cohort of healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Josef Flammer, MD
role: Study Director
affiliation: University of Basel, Dept. of Ophthalmology
facility: 
country: Switzerland
responsible party type: Sponsor