<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/NCT02989909</url>
  </required_header>
  <id_info>
    <org_study_id>CATS Tonometer, LLC - CP-01</org_study_id>
    <nct_id>NCT02989909</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of CATS Tonometer Prism</brief_title>
  <official_title>Clinical Evaluation of CATS Tonometer Prism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuor Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuor Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open-labeled, randomized, controlled, multicenter study at two clinical&#xD;
      investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure&#xD;
      measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).&#xD;
&#xD;
      Of the 200 eyes, at least 10 highly astigmatic eyes (&gt;3 D of corneal astigmatism) each in the&#xD;
      low, medium and high IOP ranges shall have the same clinical testing and analysis of results,&#xD;
      with the analysis kept separate from that of the main group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.</measure>
    <time_frame>From date of randomization until 24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Goldmann Tonometer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CATS tonometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CATS tonometer prism</intervention_name>
    <description>demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range</description>
    <arm_group_label>CATS tonometer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Goldmann tonometer prism</intervention_name>
    <description>demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range</description>
    <arm_group_label>Goldmann Tonometer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent (and assent when applicable)obtained from subject or&#xD;
             subject's legal representative and ability for subject to comply with the requirements&#xD;
             of the study.&#xD;
&#xD;
          -  Male and female patients, at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has undergone ocular surgery within the last 3 months&#xD;
&#xD;
          -  Uncontrolled systemic disease that in the opinion of the Investigator would put the&#xD;
             subject's heath at risk&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Subjects with only one functional eye&#xD;
&#xD;
          -  Those with one eye having poor or eccentric fixation&#xD;
&#xD;
          -  Eyes displaying an oval contact image&#xD;
&#xD;
          -  Those with corneal scarring or who have had corneal surgery including corneal laser&#xD;
             surgery&#xD;
&#xD;
          -  Microphthalmos&#xD;
&#xD;
          -  Buphthalmos&#xD;
&#xD;
          -  Contact lens wearers&#xD;
&#xD;
          -  Severe Dry eyes&#xD;
&#xD;
          -  Lid squeezers - blepharospasm&#xD;
&#xD;
          -  Nystagmus&#xD;
&#xD;
          -  Keratoconus&#xD;
&#xD;
          -  Any other corneal or conjunctival pathology or infection.&#xD;
&#xD;
          -  Central corneal thickness greater than 0.600 mm or less than 0.500 mm (2 standard&#xD;
             deviations about the human mean)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Eye Consultants</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocular Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 6, 2019</submitted>
    <returned>August 23, 2019</returned>
  </pending_results>
  <!-- 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/NCT02989909
org study id: CATS Tonometer, LLC - CP-01
nct id: NCT02989909
lead sponsor: 
has dmc: No
Prospective, open-labeled, randomized, controlled, multicenter study at two clinical
      investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure
      measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).

      Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the
      low, medium and high IOP ranges shall have the same clinical testing and analysis of results,
      with the analysis kept separate from that of the main group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
time frame: From date of randomization until 24 hours
arm group label: Goldmann Tonometer
arm group type: Active Comparator
description: Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism
arm group label: CATS tonometer
arm group type: Experimental
description: CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism
intervention type: Device
intervention name: CATS tonometer prism
description: demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
arm group label: CATS tonometer
intervention type: Device
intervention name: Goldmann tonometer prism
description: demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
arm group label: Goldmann Tonometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ocular Hypertension
sharing ipd: No
submitted: August 6, 2019
returned: August 23, 2019