<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/NCT02206594</url>
  </required_header>
  <id_info>
    <org_study_id>MCW-EI-001</org_study_id>
    <nct_id>NCT02206594</nct_id>
  </id_info>
  <brief_title>Combined Cataract Surgery and Planned Descemetorhexis</brief_title>
  <official_title>Combined Cataract Surgery and Planned Descemetorhexis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment&#xD;
      of Fuchs' corneal dystrophy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Actual">August 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal clarity as assessed by slit lamp photography</measure>
    <time_frame>Assessed up to 1 year following descemetorhexis</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resolution of edema as assessed by slit lamp photography</measure>
    <time_frame>Assessed up to 1 year following descemetorhexis</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Reconstitution of the endothelial cell layer as assessed by specular microscopy</measure>
    <time_frame>Assessed up to 1 year following descemetorhexis</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Fuchs' Corneal Dystrophy</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Descemetorhexis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Descemetorhexis</intervention_name>
    <arm_group_label>Descemetorhexis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          -  Patient &gt;18 years old&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
        Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):&#xD;
&#xD;
          -  Fuchs' corneal dystrophy diagnosed&#xD;
&#xD;
          -  Cataract present&#xD;
&#xD;
          -  Best corrected visual acuity ≤ 20/40&#xD;
&#xD;
          -  Candidate for current endothelial transplant procedure (DSAEK, DMEK)&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  Medically unstable patient&#xD;
&#xD;
          -  Monocular patient&#xD;
&#xD;
          -  Unwilling or unable to provide informed consent&#xD;
&#xD;
        Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):&#xD;
&#xD;
          -  Corneal dystrophy other than Fuchs'&#xD;
&#xD;
          -  Central corneal scar or central opacity not related to Fuchs'&#xD;
&#xD;
          -  Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy&#xD;
&#xD;
          -  History of prior vitreoretinal surgery&#xD;
&#xD;
          -  Advanced or unstable glaucoma&#xD;
&#xD;
          -  Known steroid responders with glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>April 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>August 20, 2015</last_update_submitted>
  <last_update_submitted_qc>August 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Steve Koenig</investigator_full_name>
    <investigator_title>Steven B. Koenig, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Corneal Dystrophies, Hereditary</mesh_term>
    <mesh_term>Fuchs' Endothelial Dystrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02206594
org study id: MCW-EI-001
nct id: NCT02206594
lead sponsor: 
has dmc: No
A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment
      of Fuchs' corneal dystrophy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Corneal clarity as assessed by slit lamp photography
time frame: Assessed up to 1 year following descemetorhexis
measure: Resolution of edema as assessed by slit lamp photography
time frame: Assessed up to 1 year following descemetorhexis
measure: Reconstitution of the endothelial cell layer as assessed by specular microscopy
time frame: Assessed up to 1 year following descemetorhexis
arm group label: Descemetorhexis
arm group type: Experimental
intervention type: Procedure
intervention name: Descemetorhexis
arm group label: Descemetorhexis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Steve Koenig
investigator title: Steven B. Koenig, MD
mesh term: Cataract
mesh term: Corneal Dystrophies, Hereditary
mesh term: Fuchs' Endothelial Dystrophy