<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/NCT02215109</url>
  </required_header>
  <id_info>
    <org_study_id>KNUHOPH2014-01</org_study_id>
    <nct_id>NCT02215109</nct_id>
  </id_info>
  <brief_title>Retinal Vessel Diameter in Branch Retinal Vein Occlusion</brief_title>
  <official_title>Change of Retinal Vessel Diameter in Branch Retinal Vein Occlusion After Intravitreal Bevacizumab Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The authors investigated the consecutive change of retinal vessel's diameter in affected eye&#xD;
      and fellow eye of Branch Retinal Vein Occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty five consecutive patients who had undergone intravitreal bevacizumab injection for&#xD;
      Branch Retinal Vein Occlusion with macular edema were included in this study. All subjects&#xD;
      were enrolled between April, 2012 and April, 2013 in the Department of Ophthalmology,&#xD;
      Kyungpook National University Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion</measure>
    <time_frame>0, 1, 3, and 6 months</time_frame>
    <description>To evaluate the change of unoccluded retinal vessel diameter in affected eye of Branch Retinal Vein Occlusion and unaffected fellow eye.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Branch Retinal Vein Occlusion</condition>
  <arm_group>
    <arm_group_label>BRVO, Retinal vessel diameter</arm_group_label>
    <description>The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 25 patients will be included. All subjects with branch retinal vein occlusion&#xD;
        scheduled for intravitreal bevacizumab injection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Best-corrected visual acuity less than 20/40&#xD;
&#xD;
          -  Central subfield macular thickness (CSMT) 300 μm or greater on spectral-domain optical&#xD;
             coherence tomography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recurrent BRVO&#xD;
&#xD;
          -  History of previous treatments for BRVO including vitreoretinal surgery, intravitreal&#xD;
             injection, subtenon injection or laser photocoagulation&#xD;
&#xD;
          -  Patients with diabetes or dyslipidemia&#xD;
&#xD;
          -  IOP ≥ 22mmHg, treatment for glaucoma, a family history of glaucoma, or optic&#xD;
             neuropathy&#xD;
&#xD;
          -  High myopia (&lt;-6 Diopters), high hyperopia (&gt;6 Diopters) or a history of refractive&#xD;
             surgeries&#xD;
&#xD;
          -  Co-existing retinal disease other than BRVO&#xD;
&#xD;
          -  Corneal diseases include ulcer, keratoconus and a history of corneal laceration&#xD;
&#xD;
          -  Cataract and other media opacities resulting in visual impairment or poor fundus&#xD;
             images&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong Ho Park, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dong Ho Park</name>
      <address>
        <city>Daegu</city>
        <state>Kyungsangpookdo</state>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 29, 2016</last_update_submitted>
  <last_update_submitted_qc>August 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Dong Ho Park</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Vein Occlusion</mesh_term>
  </condition_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/NCT02215109
org study id: KNUHOPH2014-01
nct id: NCT02215109
lead sponsor: 
has dmc: Yes
The authors investigated the consecutive change of retinal vessel's diameter in affected eye
      and fellow eye of Branch Retinal Vein Occlusion.
Twenty five consecutive patients who had undergone intravitreal bevacizumab injection for
      Branch Retinal Vein Occlusion with macular edema were included in this study. All subjects
      were enrolled between April, 2012 and April, 2013 in the Department of Ophthalmology,
      Kyungpook National University Hospital.
observational model: Case-Only
time perspective: Prospective
measure: Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion
time frame: 0, 1, 3, and 6 months
description: To evaluate the change of unoccluded retinal vessel diameter in affected eye of Branch Retinal Vein Occlusion and unaffected fellow eye.
arm group label: BRVO, Retinal vessel diameter
description: The retinal vessel diameter was measured Branch Retinal Vein Occlusion patients after intravitreal bevacizumab injection.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dong Ho Park, M.D.
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Dong Ho Park
investigator title: Clinical professor
mesh term: Retinal Vein Occlusion
sharing ipd: No