<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/NCT02990169</url>
  </required_header>
  <id_info>
    <org_study_id>CATS and Corneal Thickness</org_study_id>
    <nct_id>NCT02990169</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of CATS Tonometer Prism</brief_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </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;
      Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based&#xD;
      on standard of care vision examination at the clinical investigation sites. All subjects will&#xD;
      undergo a standard ophthalmic exam and informed consent. IOP will be measured using a&#xD;
      Goldmann tonometer armature with both the standard flat GAT prism and the modified curved&#xD;
      CATS prism alternately inserted. The only additional measurement is central corneal thickness&#xD;
      (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT&#xD;
      prism and is currently standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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.</measure>
    <time_frame>From date of randomization until 24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table.</measure>
    <time_frame>From date of randomization until 24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Ocular Hypotension</condition>
  <arm_group>
    <arm_group_label>Goldmann Tonometer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CATS tonometer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CATS tonometer prism</intervention_name>
    <description>IOP tonometer prism for assessment of intraocular pressure</description>
    <arm_group_label>CATS tonometer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Goldmann Tonometer prism</intervention_name>
    <description>IOP tonometer prism for assessment of intraocular pressure</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 between 0.600 mm and 0.500 mm (more than 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>October 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 13, 2016</study_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 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 Hypotension</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <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/NCT02990169
org study id: CATS and Corneal Thickness
nct id: NCT02990169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
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).
      Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based
      on standard of care vision examination at the clinical investigation sites. All subjects will
      undergo a standard ophthalmic exam and informed consent. IOP will be measured using a
      Goldmann tonometer armature with both the standard flat GAT prism and the modified curved
      CATS prism alternately inserted. The only additional measurement is central corneal thickness
      (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT
      prism and is currently standard of care.
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.
time frame: From date of randomization until 24 hours
measure: All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table.
time frame: From date of randomization until 24 hours
arm group label: Goldmann Tonometer
arm group type: Active Comparator
description: determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism
arm group label: CATS tonometer
arm group type: Active Comparator
description: determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism
intervention type: Device
intervention name: CATS tonometer prism
description: IOP tonometer prism for assessment of intraocular pressure
arm group label: CATS tonometer
intervention type: Device
intervention name: Goldmann Tonometer prism
description: IOP tonometer prism for assessment of intraocular pressure
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 Hypotension
mesh term: Hypotension
sharing ipd: No