xml: <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/NCT06013462</url>
    </required_header>
    <id_info>
      <org_study_id>ASD_2023_6</org_study_id>
      <nct_id>NCT06013462</nct_id>
    </id_info>
    <brief_title>DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery</brief_title>
    <acronym>DMEK complexes</acronym>
    <official_title>DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat&#xD;
        primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in&#xD;
        many Western referral centers, DMEK is currently the surgical technique of choice for the&#xD;
        treatment of primary or secondary corneal endothelial decompensation.&#xD;
  &#xD;
        Technically challenging, it is a relatively tedious surgery to learn, but offers the best&#xD;
        visual and refractive results, as well as faster visual and functional recovery in simple&#xD;
        cases.&#xD;
  &#xD;
        In patients without anterior or posterior segment surgical history, the complication rate of&#xD;
        DMEK, including graft rejection, is similar to that of other endothelial keratoplasty&#xD;
        surgical techniques.&#xD;
  &#xD;
        However, in specific cases, in patients with a history of ophthalmological surgery such as&#xD;
        vitrectomy, trabeculectomy, large iris defects, anterior synechiae, aniridia or aphakia, the&#xD;
        scientific literature shows a higher complication rate for DMEK (increased rate of rebulling&#xD;
        and graft decompensation).&#xD;
  &#xD;
        As a result, other techniques that are less effective on visual results continue to be used&#xD;
        for these patients in a large number of centers.&#xD;
  &#xD;
        Nonetheless, in our department, DMEK is also performed on these complicated patients.&#xD;
  &#xD;
        When it comes to patients with a history of anterior or posterior segment surgery, it seems&#xD;
        to us that the surgeons' experience with DMEK allows better visual results than with any&#xD;
        other technique, but without any back up regarding the complication rate in the literature.&#xD;
  &#xD;
        The main aim of this study is to describe, in patients with a history of anterior or&#xD;
        posterior segment surgery undergoing DMEK, the 12-months occurrence rate of at least one&#xD;
        serious post-operative complication.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Occurrence rate of at least one serious DMEK post-op complication</measure>
      <time_frame>12 months</time_frame>
      <description>Composite endpoint made of 4 serious post-op complications :&#xD;
  Rebulling : graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber.&#xD;
  Graft failure : no improvement in pachymetry at three months post-op (Avanti OCT-cornea).&#xD;
  Graft rejection : presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry &gt; 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination).&#xD;
  Macular cystoid edema : presence of intraretinal fluid in the macular area (macular OCT).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rebulling occurrence rate</measure>
      <time_frame>12 months</time_frame>
      <description>Graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft failure occurrence rate</measure>
      <time_frame>12 months</time_frame>
      <description>No improvement in pachymetry at three months post-op (Avanti OCT-cornea).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft rejection occurrence rate</measure>
      <time_frame>12 months</time_frame>
      <description>Presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry &gt; 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macular cystoid edema occurrence rate</measure>
      <time_frame>12 months</time_frame>
      <description>Presence of intraretinal fluid in the macular area (macular OCT).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraocular hypertension occurrence rate</measure>
      <time_frame>12 months</time_frame>
      <description>Intraocular pressure greater than 21mmHg measured by pneumotonometer or applanation tonometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft detachment (with or without rebulling) occurrence rate</measure>
      <time_frame>12 months</time_frame>
      <description>Failure of the graft to press against the posterior host corneal stroma (Avanti OCT-cornea and slit-lamp biomicroscopic examination).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgeon's subjective assessment of surgical complexity</measure>
      <time_frame>Right after the completion of the surgery</time_frame>
      <description>Evaluation by the main surgeon at the end of the procedure, on a Likert scale from 0 to 10 (0 being normal, uncomplicated surgery and 10 being the maximum level of complexity encountered).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of surgical procedure (in minutes)</measure>
      <time_frame>Right after the completion of the surgery</time_frame>
      <description>The start of the procedure is defined by the placement of the blepharostat and the end of the procedure is defined by the end of the lens dressing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of visual results (corrected and uncorrected)</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Measurements with optotypes :&#xD;
  Best monocular visual acuity (decimal scale converted to logMAR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of visual results (corrected and uncorrected)</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Measurements with optotypes :&#xD;
  Best monocular visual acuity (decimal scale converted to logMAR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of visual results (corrected and uncorrected)</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>Measurements with optotypes :&#xD;
  Best monocular visual acuity (decimal scale converted to logMAR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of visual results (corrected and uncorrected)</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Measurements with optotypes :&#xD;
  Best monocular visual acuity (decimal scale converted to logMAR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of refractive results</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Nidek® autorefractometer measurement :&#xD;
  Sphere (in dioptres)&#xD;
  Cylinder (in dioptres)&#xD;
  Spherical equivalent (in dioptres)&#xD;
  Cylinder axis (in degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of refractive results</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Nidek® autorefractometer measurement :&#xD;
  Sphere (in dioptres)&#xD;
  Cylinder (in dioptres)&#xD;
  Spherical equivalent (in dioptres)&#xD;
  Cylinder axis (in degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of refractive results</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>Nidek® autorefractometer measurement :&#xD;
  Sphere (in dioptres)&#xD;
  Cylinder (in dioptres)&#xD;
  Spherical equivalent (in dioptres)&#xD;
  Cylinder axis (in degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of refractive results</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Nidek® autorefractometer measurement :&#xD;
  Sphere (in dioptres)&#xD;
  Cylinder (in dioptres)&#xD;
  Spherical equivalent (in dioptres)&#xD;
  Cylinder axis (in degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of endothelial loss</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of endothelial loss</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of endothelial loss</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of endothelial loss</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of corneal thickness</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Corneal thickness in μm measured by OCT - Avanti® type cornea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of corneal thickness</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Corneal thickness in μm measured by OCT - Avanti® type cornea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of corneal thickness</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>Corneal thickness in μm measured by OCT - Avanti® type cornea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of corneal thickness</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Corneal thickness in μm measured by OCT - Avanti® type cornea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of posterior keratometry</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of posterior keratometry</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of posterior keratometry</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of posterior keratometry</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Descemet Membrane Endothelial Keratoplasty</intervention_name>
      <description>DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Group of 80 patients admitted for consultation at the Hôpital Fondation Adolphe de&#xD;
          Rothschild up to one year prior to endothelial transplantation and meeting the above&#xD;
          eligibility criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria :&#xD;
  &#xD;
            -  Patients scheduled for corneal endothelial transplantation in one or both eyes&#xD;
  &#xD;
            -  History of vitrectomy, trabeculectomy, large iris defects, anterior synechiae on the&#xD;
               eye to be operated on&#xD;
  &#xD;
            -  Pseudophakia or aphakia in the eye to be operated on&#xD;
  &#xD;
            -  Express consent to participate in the study&#xD;
  &#xD;
            -  Affiliated or beneficiary of a social security scheme&#xD;
  &#xD;
          Exclusion Criteria :&#xD;
  &#xD;
            -  Need for combined PKE + EK surgery&#xD;
  &#xD;
            -  Primary endothelial decompensation&#xD;
  &#xD;
            -  At least one contraindication to endothelial transplantation :&#xD;
  &#xD;
                 -  Presence of a stromal corneal cleft&#xD;
  &#xD;
                 -  Inflammatory or degenerative corneal pathology other than endothelial&#xD;
  &#xD;
                 -  Progressive corneal infection&#xD;
  &#xD;
                 -  Degenerative retinal pathology not allowing visual recovery postoperatively (for&#xD;
                    the purposes of this study, we accept patients who have had retinal detachment&#xD;
                    and whose loss of vision is clearly attributable to endothelial decompensation)&#xD;
  &#xD;
                 -  End-stage glaucoma not allowing visual recovery post-operatively (for this study,&#xD;
                    we accept patients who have had filtering surgery for glaucoma, which is&#xD;
                    stabilized at the time of surgery. Decline in vision must be clearly attributable&#xD;
                    to endothelial decompensation)&#xD;
  &#xD;
            -  Personal history of corneal transplantation on the eye to be operated on&#xD;
  &#xD;
            -  Medical contraindication to general or local anesthesia&#xD;
  &#xD;
            -  Patient under legal protection&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013462
  org study id: ASD_2023_6
  nct id: NCT06013462
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat
        primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in
        many Western referral centers, DMEK is currently the surgical technique of choice for the
        treatment of primary or secondary corneal endothelial decompensation.
  
        Technically challenging, it is a relatively tedious surgery to learn, but offers the best
        visual and refractive results, as well as faster visual and functional recovery in simple
        cases.
  
        In patients without anterior or posterior segment surgical history, the complication rate of
        DMEK, including graft rejection, is similar to that of other endothelial keratoplasty
        surgical techniques.
  
        However, in specific cases, in patients with a history of ophthalmological surgery such as
        vitrectomy, trabeculectomy, large iris defects, anterior synechiae, aniridia or aphakia, the
        scientific literature shows a higher complication rate for DMEK (increased rate of rebulling
        and graft decompensation).
  
        As a result, other techniques that are less effective on visual results continue to be used
        for these patients in a large number of centers.
  
        Nonetheless, in our department, DMEK is also performed on these complicated patients.
  
        When it comes to patients with a history of anterior or posterior segment surgery, it seems
        to us that the surgeons' experience with DMEK allows better visual results than with any
        other technique, but without any back up regarding the complication rate in the literature.
  
        The main aim of this study is to describe, in patients with a history of anterior or
        posterior segment surgery undergoing DMEK, the 12-months occurrence rate of at least one
        serious post-operative complication.
  observational model: Cohort
  time perspective: Prospective
  measure: Occurrence rate of at least one serious DMEK post-op complication
  time frame: 12 months
  description: Composite endpoint made of 4 serious post-op complications :
  Rebulling : graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber.
  Graft failure : no improvement in pachymetry at three months post-op (Avanti OCT-cornea).
  Graft rejection : presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry > 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
  Macular cystoid edema : presence of intraretinal fluid in the macular area (macular OCT).
  measure: Rebulling occurrence rate
  time frame: 12 months
  description: Graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber.
  measure: Graft failure occurrence rate
  time frame: 12 months
  description: No improvement in pachymetry at three months post-op (Avanti OCT-cornea).
  measure: Graft rejection occurrence rate
  time frame: 12 months
  description: Presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry > 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
  measure: Macular cystoid edema occurrence rate
  time frame: 12 months
  description: Presence of intraretinal fluid in the macular area (macular OCT).
  measure: Intraocular hypertension occurrence rate
  time frame: 12 months
  description: Intraocular pressure greater than 21mmHg measured by pneumotonometer or applanation tonometer.
  measure: Graft detachment (with or without rebulling) occurrence rate
  time frame: 12 months
  description: Failure of the graft to press against the posterior host corneal stroma (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
  measure: Surgeon's subjective assessment of surgical complexity
  time frame: Right after the completion of the surgery
  description: Evaluation by the main surgeon at the end of the procedure, on a Likert scale from 0 to 10 (0 being normal, uncomplicated surgery and 10 being the maximum level of complexity encountered).
  measure: Duration of surgical procedure (in minutes)
  time frame: Right after the completion of the surgery
  description: The start of the procedure is defined by the placement of the blepharostat and the end of the procedure is defined by the end of the lens dressing.
  measure: Evolution of visual results (corrected and uncorrected)
  time frame: 1 month after surgery
  description: Measurements with optotypes :
  Best monocular visual acuity (decimal scale converted to logMAR)
  measure: Evolution of visual results (corrected and uncorrected)
  time frame: 3 months after surgery
  description: Measurements with optotypes :
  Best monocular visual acuity (decimal scale converted to logMAR)
  measure: Evolution of visual results (corrected and uncorrected)
  time frame: 6 months after surgery
  description: Measurements with optotypes :
  Best monocular visual acuity (decimal scale converted to logMAR)
  measure: Evolution of visual results (corrected and uncorrected)
  time frame: 12 months after surgery
  description: Measurements with optotypes :
  Best monocular visual acuity (decimal scale converted to logMAR)
  measure: Evolution of refractive results
  time frame: 1 month after surgery
  description: Nidek® autorefractometer measurement :
  Sphere (in dioptres)
  Cylinder (in dioptres)
  Spherical equivalent (in dioptres)
  Cylinder axis (in degrees)
  measure: Evolution of refractive results
  time frame: 3 months after surgery
  description: Nidek® autorefractometer measurement :
  Sphere (in dioptres)
  Cylinder (in dioptres)
  Spherical equivalent (in dioptres)
  Cylinder axis (in degrees)
  measure: Evolution of refractive results
  time frame: 6 months after surgery
  description: Nidek® autorefractometer measurement :
  Sphere (in dioptres)
  Cylinder (in dioptres)
  Spherical equivalent (in dioptres)
  Cylinder axis (in degrees)
  measure: Evolution of refractive results
  time frame: 12 months after surgery
  description: Nidek® autorefractometer measurement :
  Sphere (in dioptres)
  Cylinder (in dioptres)
  Spherical equivalent (in dioptres)
  Cylinder axis (in degrees)
  measure: Evolution of endothelial loss
  time frame: 1 month after surgery
  description: Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
  measure: Evolution of endothelial loss
  time frame: 3 months after surgery
  description: Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
  measure: Evolution of endothelial loss
  time frame: 6 months after surgery
  description: Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
  measure: Evolution of endothelial loss
  time frame: 12 months after surgery
  description: Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
  measure: Evolution of corneal thickness
  time frame: 1 month after surgery
  description: Corneal thickness in μm measured by OCT - Avanti® type cornea.
  measure: Evolution of corneal thickness
  time frame: 3 months after surgery
  description: Corneal thickness in μm measured by OCT - Avanti® type cornea.
  measure: Evolution of corneal thickness
  time frame: 6 months after surgery
  description: Corneal thickness in μm measured by OCT - Avanti® type cornea.
  measure: Evolution of corneal thickness
  time frame: 12 months after surgery
  description: Corneal thickness in μm measured by OCT - Avanti® type cornea.
  measure: Evolution of posterior keratometry
  time frame: 1 month after surgery
  description: Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
  measure: Evolution of posterior keratometry
  time frame: 3 months after surgery
  description: Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
  measure: Evolution of posterior keratometry
  time frame: 6 months after surgery
  description: Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
  measure: Evolution of posterior keratometry
  time frame: 12 months after surgery
  description: Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
  intervention type: Procedure
  intervention name: Descemet Membrane Endothelial Keratoplasty
  description: DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor