<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/NCT01729975</url>
  </required_header>
  <id_info>
    <org_study_id>CEM-530-US-001</org_study_id>
    <nct_id>NCT01729975</nct_id>
  </id_info>
  <brief_title>Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness</brief_title>
  <official_title>Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, ％Hexagonality, and Central Corneal Thickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nidek Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nidek Co. LTD.</source>
  <brief_summary>
    <textblock>
      The primary objective of this clinical study is to collect clinical data to support an FDA&#xD;
      510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to&#xD;
      evaluate any adverse events found during the clinical study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">October 2012</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>Corneal and Endothelial Cell Measurements</measure>
    <time_frame>single time point - 1 day</time_frame>
    <description>Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Corneal and Endothelial Cell Measurements</condition>
  <arm_group>
    <arm_group_label>18-28 years old Non-pathologic</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>29-80 years old Non-Pathologic</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>29-80 years old pathologic corneal disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Ophthalmology Practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal&#xD;
             capacity to volunteer on the date the informed consent is signed. Subjects who follow&#xD;
             the instructions by Principal/Clinical investigator or clinical staff at the clinical&#xD;
             site, and can visit on a scheduled examination date.&#xD;
&#xD;
          -  Pathologic: Male and female subjects from 29 to 80 years old who have full legal&#xD;
             capacity to volunteer on the date the informed consent is signed. Subjects who follow&#xD;
             the instructions by Principal/Clinical investigator or clinical staff at the clinical&#xD;
             site, and can visit on a scheduled examination date and subjects who have any of the&#xD;
             following conditions:&#xD;
&#xD;
               -  History of Post-op surgical trauma including, Psudophakic or Aphakic blous&#xD;
                  keratopathy or glaucoma surgery&#xD;
&#xD;
               -  History of corneal transplant&#xD;
&#xD;
               -  Physical injury or trauma to the cornea&#xD;
&#xD;
               -  Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy)&#xD;
&#xD;
               -  Keratoconus&#xD;
&#xD;
               -  Long term PMMA contact lens use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-Pathologic subjects who have the following conditions:&#xD;
&#xD;
               -  Long term Diabetes&#xD;
&#xD;
               -  Dementia&#xD;
&#xD;
               -  Subjects who have other life threatening and/or debilitating systemic diseases&#xD;
&#xD;
               -  History of corneal transplant&#xD;
&#xD;
               -  Long term Fuch's dystrophy (and other corneal endothelial dystrophy)&#xD;
&#xD;
               -  Keratoconus&#xD;
&#xD;
               -  Guttata&#xD;
&#xD;
               -  Diabetic retinopathy&#xD;
&#xD;
               -  History of cataract or ocular surgical procedures that render the cornea opaque&#xD;
                  or otherwise impact its ability to be imaged using the investigational device.&#xD;
&#xD;
               -  All contact lens wearers&#xD;
&#xD;
          -  Pathologic subjects who have Dementia or who have other life threatening and/or&#xD;
             debilitating systemic diseases&#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>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</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>


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/NCT01729975
org study id: CEM-530-US-001
nct id: NCT01729975
lead sponsor: 
The primary objective of this clinical study is to collect clinical data to support an FDA
      510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to
      evaluate any adverse events found during the clinical study.
observational model: Cohort
time perspective: Prospective
measure: Corneal and Endothelial Cell Measurements
time frame: single time point - 1 day
description: Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements
arm group label: 18-28 years old Non-pathologic
arm group label: 29-80 years old Non-Pathologic
arm group label: 29-80 years old pathologic corneal disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor