<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/NCT04469933</url>
  </required_header>
  <id_info>
    <org_study_id>2020-03ObsCHRMT</org_study_id>
    <nct_id>NCT04469933</nct_id>
  </id_info>
  <brief_title>Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)</brief_title>
  <acronym>GOODRMEK</acronym>
  <official_title>Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes</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>
      Aim: Identify predictive factors of good results after primary Descemet's Membrane&#xD;
      Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).&#xD;
&#xD;
      82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between&#xD;
      March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic&#xD;
      criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15&#xD;
      post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and&#xD;
      postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients'&#xD;
      ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: Identify predictive factors of good results after primary Descemet's Membrane&#xD;
      Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).&#xD;
&#xD;
      A monocentric retrospective observational study was realized at the Regional Hospital Center&#xD;
      of Metz-Thionville, Mercy Hospital, Metz, France.&#xD;
&#xD;
      102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK&#xD;
      between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied&#xD;
      prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between&#xD;
      pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell&#xD;
      density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors'&#xD;
      and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with&#xD;
      cataract surgery). Surgery was considered successful when best spectacle corrected visual&#xD;
      acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-operative Central Corneal Thickness (CCT),</measure>
    <time_frame>day 1</time_frame>
    <description>Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative Central Corneal Thickness (CCT),</measure>
    <time_frame>Months 12</time_frame>
    <description>Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CCT's delta</measure>
    <time_frame>day 15</time_frame>
    <description>CCT's delta (μm) between pre and D15 post-operatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>anterior mean keratometry</measure>
    <time_frame>day 1</time_frame>
    <description>anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pre-operative endothelial cell density ECD</measure>
    <time_frame>day1</time_frame>
    <description>pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative endothelial cell density (ECD)</measure>
    <time_frame>6 months</time_frame>
    <description>post-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative endothelial cell density (ECD)</measure>
    <time_frame>12 months</time_frame>
    <description>post-operative ECD at 12 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pre-operative Visual Acuity</measure>
    <time_frame>day 1</time_frame>
    <description>pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>donors' and recipients' ages</measure>
    <time_frame>day 1</time_frame>
    <description>donors' and recipients' ages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recipients' sex</measure>
    <time_frame>day 1</time_frame>
    <description>recipients' sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of rebubbling</measure>
    <time_frame>months 6</time_frame>
    <description>the rate of rebubbling %(postoperative graft detachment)</description>
  </secondary_outcome>
  <enrollment type="Actual">102</enrollment>
  <condition>Endothelial Corneal Dystrophy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Included patients' were over 18, had advanced FECD associated with visual symptoms and&#xD;
        reduced visual acuity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18,&#xD;
&#xD;
          -  had advanced FECD associated with visual symptoms and reduced visual acuity .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior intraocular surgery other than cataract&#xD;
&#xD;
          -  Other indications for DMEK surgeries than FECD,&#xD;
&#xD;
          -  Eyes with corneal (except FECD), retinal or optic nerve diseases&#xD;
&#xD;
          -  Per-operative difficulties (tear's graft or complicated unfolding graft)&#xD;
&#xD;
          -  Primary graft failure (cornea that failed to clear in the presence of an attached&#xD;
             graft)&#xD;
&#xD;
          -  Secondary graft failure (corneal decompensation after an initial period of a&#xD;
             functional graft)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jean Marc PERONE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Metz Thionville</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fuchs endothelial corneal dystrophy</keyword>
  <keyword>central corneal thickness</keyword>
  <keyword>endothelial cell density</keyword>
  <keyword>keratometry</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/NCT04469933
org study id: 2020-03ObsCHRMT
nct id: NCT04469933
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: Identify predictive factors of good results after primary Descemet's Membrane
      Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).

      82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between
      March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic
      criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15
      post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and
      postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients'
      ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).
Aim: Identify predictive factors of good results after primary Descemet's Membrane
      Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).

      A monocentric retrospective observational study was realized at the Regional Hospital Center
      of Metz-Thionville, Mercy Hospital, Metz, France.

      102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK
      between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied
      prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between
      pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell
      density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors'
      and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with
      cataract surgery). Surgery was considered successful when best spectacle corrected visual
      acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.
observational model: Case-Only
time perspective: Retrospective
measure: Pre-operative Central Corneal Thickness (CCT),
time frame: day 1
description: Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
measure: Post-operative Central Corneal Thickness (CCT),
time frame: Months 12
description: Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
measure: CCT's delta
time frame: day 15
description: CCT's delta (μm) between pre and D15 post-operatively
measure: anterior mean keratometry
time frame: day 1
description: anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)
measure: pre-operative endothelial cell density ECD
time frame: day1
description: pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
measure: post-operative endothelial cell density (ECD)
time frame: 6 months
description: post-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
measure: post-operative endothelial cell density (ECD)
time frame: 12 months
description: post-operative ECD at 12 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
measure: pre-operative Visual Acuity
time frame: day 1
description: pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)
measure: donors' and recipients' ages
time frame: day 1
description: donors' and recipients' ages
measure: recipients' sex
time frame: day 1
description: recipients' sex
measure: rate of rebubbling
time frame: months 6
description: the rate of rebubbling %(postoperative graft detachment)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jean Marc PERONE, MD
role: Principal Investigator
affiliation: CHR Metz Thionville
responsible party type: Sponsor
mesh term: Corneal Dystrophies, Hereditary