<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/NCT04420429</url>
  </required_header>
  <id_info>
    <org_study_id>BeyogluEREH</org_study_id>
    <nct_id>NCT04420429</nct_id>
  </id_info>
  <brief_title>The Effect Of Preoperative Parameters On Success After DMEK Surgery</brief_title>
  <official_title>The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beyoglu Eye Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beyoglu Eye Research and Education Hospital</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>
      The aim of this study is to evaluate the effect of preoperative parameters on surgical&#xD;
      results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery;&#xD;
      preoperative anterior chamber depth, angle parameters, axial length and corneal parameters&#xD;
      will be evaluated. The effects of these parameters on surgical results will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">July 10, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Change in visual acuity</measure>
    <time_frame>Baseline and after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in endothelial cell density</measure>
    <time_frame>after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone</measure>
    <time_frame>Baseline and after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anterior chamber depth</measure>
    <time_frame>Baseline and after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in axial length</measure>
    <time_frame>Baseline and after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in central pachymetry</measure>
    <time_frame>Baseline and after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intraocular pressure</measure>
    <time_frame>Baseline and after surgery 1, 3, 6, and 12 months</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Surgical complications</measure>
    <time_frame>During surgery</time_frame>
    <description>Complications occurring during the surgery will be recorded.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Fuchs' Endothelial Dystrophy</condition>
  <condition>Pseudophakic Bullous Keratopathy</condition>
  <condition>Descemet's Membrane; Defect</condition>
  <condition>Herpetic Keratitis</condition>
  <condition>Angle's Classification</condition>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>All patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Descemet membrane endothelial keratoplasty (DMEK)</intervention_name>
    <description>All participants underwent DMEK surgery</description>
    <arm_group_label>Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who developed pseudophakic bullous keratopathy, Fuchs endothelial dystrophy,&#xD;
        endothelial insufficiency after herpetic endotheliitis and associated permanent corneal&#xD;
        edema and therefore DMEK surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK)&#xD;
&#xD;
          -  aged 18 old older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with corneal pathology other than endothelial insufficiency&#xD;
&#xD;
          -  Glaucoma patients,&#xD;
&#xD;
          -  Patients who have previously had any keratoplasty procedure&#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>Semih Çakmak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beyoglu Eye Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beyoğlu Eye Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34420</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beyoglu Eye Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>Semih Çakmak</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Descemet Membrane</keyword>
  <keyword>anterior chamber depth</keyword>
  <keyword>axial length</keyword>
  <keyword>endothelial count</keyword>
  <keyword>Descemet membrane endothelial keratoplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratitis, Herpetic</mesh_term>
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Keratitis</mesh_term>
    <mesh_term>Fuchs' Endothelial Dystrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04420429/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04420429/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04420429
org study id: BeyogluEREH
nct id: NCT04420429
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effect of preoperative parameters on surgical
      results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.
In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery;
      preoperative anterior chamber depth, angle parameters, axial length and corneal parameters
      will be evaluated. The effects of these parameters on surgical results will be examined.
observational model: Cohort
time perspective: Prospective
measure: Change in visual acuity
time frame: Baseline and after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Change in endothelial cell density
time frame: after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone
time frame: Baseline and after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Change in anterior chamber depth
time frame: Baseline and after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Change in axial length
time frame: Baseline and after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Change in central pachymetry
time frame: Baseline and after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Change in intraocular pressure
time frame: Baseline and after surgery 1, 3, 6, and 12 months
description: Change from baseline
measure: Surgical complications
time frame: During surgery
description: Complications occurring during the surgery will be recorded.
arm group label: Cohort
description: All patients
intervention type: Procedure
intervention name: Descemet membrane endothelial keratoplasty (DMEK)
description: All participants underwent DMEK surgery
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Semih Çakmak, MD
role: Principal Investigator
affiliation: Beyoglu Eye Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Beyoglu Eye Research and Education Hospital
investigator full name: Semih Çakmak
investigator title: Principal Investigator
mesh term: Keratitis, Herpetic
mesh term: Malocclusion
mesh term: Keratitis
mesh term: Fuchs' Endothelial Dystrophy
sharing ipd: No
provided document: 
provided document: 