<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/NCT01695655</url>
  </required_header>
  <id_info>
    <org_study_id>Neovasc-6281</org_study_id>
    <nct_id>NCT01695655</nct_id>
  </id_info>
  <brief_title>Neovascularization Patterns in Corneal Graft Rejection</brief_title>
  <official_title>Neovascularization Patterns in Corneal Graft Rejection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Corneal transplantation is the most commonly performed human tissue transplant worldwide.&#xD;
      Over 40,000 corneal transplants occur in the US each year. .&#xD;
&#xD;
      This study will determine specific corneal neovascularization (CN) patterns in human corneal&#xD;
      allograft recipients to determine the characteristics that worsen the prognosis for graft&#xD;
      survival. We will test the hypothesis that specific characteristics of CN are prognostic for&#xD;
      corneal allograft rejection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hope to enroll 240 subjects into the study. These patients will be enrolled&#xD;
      prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively,&#xD;
      and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp&#xD;
      biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is&#xD;
      any neovascularization detected, permitting us to develop algorithms of CN characteristics&#xD;
      that are predictive for corneal allograft rejection and failure. The corneal tissue removed&#xD;
      during these patients' surgeries will be evaluated histopathologically to identify&#xD;
      inflammation and neovascularization to confirm and compare to what is seen clinically. There&#xD;
      will be two short questionnaires conducted at each visit to assess stress levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Corneal graft rejection</measure>
    <time_frame>0 to 2 years after transplant</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Corneal Transplant</condition>
  <arm_group>
    <arm_group_label>PKP</arm_group_label>
    <description>Subjects undergoing penetrating keratoplasty</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        subjects with indications of corneal transplant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for corneal transplant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous corneal transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roni Shtein, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Of Michigam Kellogg Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Roni Shtein</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neovascularization, Pathologic</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/NCT01695655
org study id: Neovasc-6281
nct id: NCT01695655
lead sponsor: 
has dmc: No
Corneal transplantation is the most commonly performed human tissue transplant worldwide.
      Over 40,000 corneal transplants occur in the US each year. .

      This study will determine specific corneal neovascularization (CN) patterns in human corneal
      allograft recipients to determine the characteristics that worsen the prognosis for graft
      survival. We will test the hypothesis that specific characteristics of CN are prognostic for
      corneal allograft rejection.
The investigators hope to enroll 240 subjects into the study. These patients will be enrolled
      prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively,
      and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp
      biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is
      any neovascularization detected, permitting us to develop algorithms of CN characteristics
      that are predictive for corneal allograft rejection and failure. The corneal tissue removed
      during these patients' surgeries will be evaluated histopathologically to identify
      inflammation and neovascularization to confirm and compare to what is seen clinically. There
      will be two short questionnaires conducted at each visit to assess stress levels.
observational model: Cohort
time perspective: Prospective
measure: Corneal graft rejection
time frame: 0 to 2 years after transplant
arm group label: PKP
description: Subjects undergoing penetrating keratoplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Roni Shtein, MD, MS
role: Principal Investigator
affiliation: University Of Michigam Kellogg Eye Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Roni Shtein
investigator title: Assistant Professor
mesh term: Neovascularization, Pathologic
sharing ipd: No