<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/NCT04424550</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01Obs-CHRMT</org_study_id>
    <nct_id>NCT04424550</nct_id>
  </id_info>
  <brief_title>Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy</brief_title>
  <acronym>DEMOGRAFT</acronym>
  <official_title>Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional Metz-Thionville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK&#xD;
      and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous&#xD;
      Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle&#xD;
      corrected visual acuity (BSCVA) 12 months postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK,&#xD;
      DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic&#xD;
      Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best&#xD;
      spectacle corrected visual acuity (BSCVA) 12 months postoperatively.&#xD;
&#xD;
      In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110),&#xD;
      UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior&#xD;
      lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3&#xD;
      logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively&#xD;
      were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8,&#xD;
      D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity&#xD;
      (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative&#xD;
      visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT)&#xD;
      measurements carried out either pre-operatively (less than or greater than 130 µm) or&#xD;
      post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft,&#xD;
      Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate,&#xD;
      preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at&#xD;
      12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>24 months</time_frame>
    <description>The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>central graft thickness measurements</measure>
    <time_frame>6 months</time_frame>
    <description>central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of endothelial graft</measure>
    <time_frame>days 1</time_frame>
    <description>Type of endothelial graft</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Donor's ages</measure>
    <time_frame>days 1</time_frame>
    <description>Donor's ages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recipient's ages</measure>
    <time_frame>day 1</time_frame>
    <description>recipient's ages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft's endothelial cell density</measure>
    <time_frame>day 1</time_frame>
    <description>Graft's endothelial cell density was evaluated via no-contact specular microscopy (NIDEK CEM-530 NIDEK CO. LTD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rebubbling rate</measure>
    <time_frame>day 1</time_frame>
    <description>Rebubbling rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative visual acuity</measure>
    <time_frame>day 1</time_frame>
    <description>Preoperative visual acuity was scored with reference to the logarithm of the minimum angle of resolution (LogMAR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>graft's indications</measure>
    <time_frame>day 1</time_frame>
    <description>The indications of the grafts are different between the DMEK groups and the DSAEK and or UT-DSAEK groups: Fuchs endothelial corneal dystrophies (FECD) and moderated pseudophakic bullous keratopathies (PBK)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical time</measure>
    <time_frame>day 1</time_frame>
    <description>surgical time</description>
  </secondary_outcome>
  <enrollment type="Actual">218</enrollment>
  <condition>Corneal Dystrophy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This retrospective study included patients who had undergone posterior lamellar&#xD;
        keratoplasty for FECD or moderate PBK indications with a minimum follow-up period of 24&#xD;
        months. The surgical procedures were either DMEK, DSAEK or UT-DSAEK and were performed by&#xD;
        the same experienced surgeon (JMP).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with&#xD;
             preoperative BSCVA of less than 0.3 logmar,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pathologies that may seriously affect VA postoperatively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Marc PERONE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Metz Thionville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chr Metz Thionville</name>
      <address>
        <city>Metz</city>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DMEK, DSAEK, UT-DSAEK, Endothelial cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Dystrophies, Hereditary</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/NCT04424550
org study id: 2020-01Obs-CHRMT
nct id: NCT04424550
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK
      and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous
      Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle
      corrected visual acuity (BSCVA) 12 months postoperatively.
The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK,
      DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic
      Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best
      spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

      In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110),
      UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior
      lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3
      logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively
      were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8,
      D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity
      (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative
      visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT)
      measurements carried out either pre-operatively (less than or greater than 130 µm) or
      post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft,
      Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate,
      preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at
      12 months.
observational model: Other
time perspective: Retrospective
measure: visual acuity
time frame: 6 months
description: The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months
measure: visual acuity
time frame: 12 months
description: The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months
measure: visual acuity
time frame: 24 months
description: The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months
measure: central graft thickness measurements
time frame: 6 months
description: central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm)
measure: Type of endothelial graft
time frame: days 1
description: Type of endothelial graft
measure: Donor's ages
time frame: days 1
description: Donor's ages
measure: recipient's ages
time frame: day 1
description: recipient's ages
measure: Graft's endothelial cell density
time frame: day 1
description: Graft's endothelial cell density was evaluated via no-contact specular microscopy (NIDEK CEM-530 NIDEK CO. LTD).
measure: Rebubbling rate
time frame: day 1
description: Rebubbling rate
measure: Preoperative visual acuity
time frame: day 1
description: Preoperative visual acuity was scored with reference to the logarithm of the minimum angle of resolution (LogMAR).
measure: graft's indications
time frame: day 1
description: The indications of the grafts are different between the DMEK groups and the DSAEK and or UT-DSAEK groups: Fuchs endothelial corneal dystrophies (FECD) and moderated pseudophakic bullous keratopathies (PBK)
measure: surgical time
time frame: day 1
description: surgical time
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean Marc PERONE, MD
role: Principal Investigator
affiliation: CHR Metz Thionville
facility: 
country: France
responsible party type: Sponsor
mesh term: Corneal Dystrophies, Hereditary