<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/NCT02977793</url>
  </required_header>
  <id_info>
    <org_study_id>TOMEY-EM4000-US-001</org_study_id>
    <nct_id>NCT02977793</nct_id>
  </id_info>
  <brief_title>Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL</brief_title>
  <official_title>Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL for the Measurements of Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomey Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomey Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium&#xD;
      by capturing an image of corneal endothelium tissues. without making contact, analyzing the&#xD;
      captured image, and calculating data such as cell density.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Endothelial cell density measurements</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of variation of endothelial cell area</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>% Hexagonality</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Central Corneal Thickness</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">81</enrollment>
  <condition>Corneal and Endothelial Cell Measurements</condition>
  <arm_group>
    <arm_group_label>Non-pathologic young adults</arm_group_label>
    <description>18-28 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-pathologic adults</arm_group_label>
    <description>29-80 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pathologic adults</arm_group_label>
    <description>29-80 years old</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tomey EM-4000 Specular Microscope</intervention_name>
    <arm_group_label>Non-pathologic adults</arm_group_label>
    <arm_group_label>Non-pathologic young adults</arm_group_label>
    <arm_group_label>Pathologic adults</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Konan CellChek XL Specular Microscope</intervention_name>
    <arm_group_label>Non-pathologic adults</arm_group_label>
    <arm_group_label>Non-pathologic young adults</arm_group_label>
    <arm_group_label>Pathologic adults</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age&#xD;
        at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the&#xD;
        exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults&#xD;
        (29-80 years old)&#xD;
&#xD;
          1. Male or female subjects from 18 to 80 years old who have full legal capacity to&#xD;
             volunteer on the date the informed consent is signed;&#xD;
&#xD;
          2. Subjects who can follow the instructions by the clinical staff at the clinical site,&#xD;
             and can attend examinations on the scheduled examination date;&#xD;
&#xD;
          3. Subjects who agree to participate in the study.&#xD;
&#xD;
        Inclusion Criteria -Pathologic adults (29-80 years old):&#xD;
&#xD;
          1. Male and female subjects from 29 to 80 years old who have full legal capacity to&#xD;
             volunteer on the date the informed consent is signed;&#xD;
&#xD;
          2. Subjects who can follow the instructions by the clinical staff at the clinical site,&#xD;
             and can attend examinations on the scheduled examination date;&#xD;
&#xD;
          3. Subjects who agree to participate in the study;&#xD;
&#xD;
          4. At least one eye with any of the following conditions:&#xD;
&#xD;
               1. History of post-op surgical trauma including pseudophakic or aphakic bullous&#xD;
                  keratopathy&#xD;
&#xD;
               2. History of corneal transplant&#xD;
&#xD;
               3. Physical injury or trauma to the cornea&#xD;
&#xD;
               4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies&#xD;
&#xD;
               5. Keratoconus&#xD;
&#xD;
               6. Long-term polymethyl methacrylate (PMMA) contact lens use (greater than 3 years).&#xD;
&#xD;
        Exclusion Criteria - Non-pathologic young adults (18-28 years old) and non-pathologic&#xD;
        adults (29-80 years old)&#xD;
&#xD;
          1. History of post-op surgical trauma including bullous keratopathy;&#xD;
&#xD;
          2. History of corneal transplant;&#xD;
&#xD;
          3. Evidence of physical injury or trauma to the cornea;&#xD;
&#xD;
          4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;&#xD;
&#xD;
          5. Keratoconus;&#xD;
&#xD;
          6. Long-term PMMA contact lens use (greater than 3 years);&#xD;
&#xD;
          7. History of cataract, refractive or ocular surgical procedures that render the cornea&#xD;
             opaque or otherwise impact its ability to be imaged using the investigational device;&#xD;
&#xD;
          8. Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL&#xD;
             images in either eye.&#xD;
&#xD;
        Exclusion Criteria - Pathologic adults (29-80 years old)&#xD;
&#xD;
          1. History of cataract, refractive or ocular surgical procedures that render the cornea&#xD;
             opaque or otherwise impact its ability to be imaged using the investigational device;&#xD;
&#xD;
          2. Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and&#xD;
             Konan CellChek XL images in either eye.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02977793
org study id: TOMEY-EM4000-US-001
nct id: NCT02977793
lead sponsor: 
has dmc: No
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium
      by capturing an image of corneal endothelium tissues. without making contact, analyzing the
      captured image, and calculating data such as cell density.
observational model: Cohort
time perspective: Prospective
measure: Endothelial cell density measurements
time frame: 1 day
measure: Coefficient of variation of endothelial cell area
time frame: 1 day
measure: % Hexagonality
time frame: 1 day
measure: Central Corneal Thickness
time frame: 1 day
measure: Adverse Events
time frame: 1 day
arm group label: Non-pathologic young adults
description: 18-28 years old
arm group label: Non-pathologic adults
description: 29-80 years old
arm group label: Pathologic adults
description: 29-80 years old
intervention type: Device
intervention name: Tomey EM-4000 Specular Microscope
arm group label: Non-pathologic adults
arm group label: Non-pathologic young adults
arm group label: Pathologic adults
intervention type: Device
intervention name: Konan CellChek XL Specular Microscope
arm group label: Non-pathologic adults
arm group label: Non-pathologic young adults
arm group label: Pathologic adults
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No