<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/NCT01733550</url>
  </required_header>
  <id_info>
    <org_study_id>s54640</org_study_id>
    <nct_id>NCT01733550</nct_id>
  </id_info>
  <brief_title>ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer</brief_title>
  <official_title>ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare glaucoma patients' own I Care measurements by the&#xD;
      standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      not necessary&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">April 2013</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>Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.</measure>
    <time_frame>immediate comparison, no time frame required</time_frame>
    <description>Patients eye pressure measurement with both devices.&#xD;
Home ICare measurement by study nurse compared to Home ICare by patient compared to Goldmann ATO by study nurse (once for every patient)&#xD;
4 times daily: measurement Goldmann ATO (by resident in ophthalmology) and home Icare (by patient)on same moment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Comfort</measure>
    <time_frame>1 day hospitalisation</time_frame>
    <description>The comfort of the patients will be checked with both methods (home iCare and goldmann applanation tonometry) and look if the patient has a preference for one of them. Pain and discomfort were scaled from 0 to 5 (0 = none,1-2 = slight, 3-4 = moderate, 5 = severe) for both tonometers, and patients were asked which tonometer they preferred.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Glaucoma patients</arm_group_label>
    <description>Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Home iCare (study nurse)</intervention_name>
    <description>the intraocular pressure is measured by iCare performed by the study nurse</description>
    <arm_group_label>Glaucoma patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>goldmann applanation tonometry</intervention_name>
    <description>the intraocular pressure is measured by goldmann applanation tonometry</description>
    <arm_group_label>Glaucoma patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>home iCare (by patient)</intervention_name>
    <description>the intraocular pressure is measured by the iCare performed by the patient him self</description>
    <arm_group_label>Glaucoma patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Glaucoma patients who are admitted to the hospital for repeated eye pressure measurements&#xD;
        learn how to handle the home i care during their stay.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ocular hypertension (OHT):with/without glaucoma drugs&#xD;
&#xD;
          -  Primary open angle glaucoma (POAG)- high pressure: Diagnosis based on optic nerve head&#xD;
             rim loss and/or visual field defects and intraocular pressure (IOP) &gt;21 mmHg.&#xD;
&#xD;
          -  Primary open angle glaucoma, normal pressure: cfr high pressure but intraocular&#xD;
             pressure ≤ 21 mmHg&#xD;
&#xD;
          -  Exfoliative Glaucoma (PEX): Diagnosis based on optic nerve head rim loss and/or visual&#xD;
             field defects and intraocular pressure (IOP) &gt;21 mmHg, with exfoliation material in&#xD;
             the anterior segment.&#xD;
&#xD;
          -  Pigmentary Glaucoma (PDG): Diagnosis based on optic nerve head rim loss and/or visual&#xD;
             field defects and intraocular pressure (IOP) &gt;21 mmHg, with Krukenberg's spindle&#xD;
             and/or pigment dispersed on the trabecular meshwork.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Other glaucoma types&#xD;
&#xD;
          -  Corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus,&#xD;
             permanent contact lens wear, recurrent corneal erosion)&#xD;
&#xD;
          -  Severe arthritis (unable to handle home i care device)&#xD;
&#xD;
          -  Lack of comprehension&#xD;
&#xD;
          -  Intra ocular surgery and laser treatment during the last 6 months&#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>
  <overall_official>
    <last_name>Ingeborg Stalmans</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sien Boons, Optometrist</last_name>
    <phone>+32-16-33-23-61</phone>
    <email>sien.boons@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evelien Dewilde, Resident</last_name>
    <phone>+32-16-33-23-61</phone>
    <email>evelien.dewilde@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZLeuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Sien Boons, Optometrist</last_name>
      <phone>+3216332361</phone>
      <email>sien.boons@uzleuven.be</email>
    </contact>
    <investigator>
      <last_name>Ingeborg Stalmans</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 27, 2012</last_update_submitted>
  <last_update_submitted_qc>November 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular Pressure</keyword>
  <keyword>Tonometry, Ocular</keyword>
  <keyword>iCare</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT01733550
org study id: s54640
nct id: NCT01733550
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare glaucoma patients' own I Care measurements by the
      standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.
not necessary
observational model: Cohort
time perspective: Prospective
measure: Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.
time frame: immediate comparison, no time frame required
description: Patients eye pressure measurement with both devices.
Home ICare measurement by study nurse compared to Home ICare by patient compared to Goldmann ATO by study nurse (once for every patient)
4 times daily: measurement Goldmann ATO (by resident in ophthalmology) and home Icare (by patient)on same moment
measure: Patient Comfort
time frame: 1 day hospitalisation
description: The comfort of the patients will be checked with both methods (home iCare and goldmann applanation tonometry) and look if the patient has a preference for one of them. Pain and discomfort were scaled from 0 to 5 (0 = none,1-2 = slight, 3-4 = moderate, 5 = severe) for both tonometers, and patients were asked which tonometer they preferred.
arm group label: Glaucoma patients
description: Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.
intervention type: Device
intervention name: Home iCare (study nurse)
description: the intraocular pressure is measured by iCare performed by the study nurse
arm group label: Glaucoma patients
intervention type: Device
intervention name: goldmann applanation tonometry
description: the intraocular pressure is measured by goldmann applanation tonometry
arm group label: Glaucoma patients
intervention type: Device
intervention name: home iCare (by patient)
description: the intraocular pressure is measured by the iCare performed by the patient him self
arm group label: Glaucoma patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ingeborg Stalmans
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
last name: Sien Boons, Optometrist
phone: +32-16-33-23-61
email: sien.boons@uzleuven.be
last name: Evelien Dewilde, Resident
phone: +32-16-33-23-61
email: evelien.dewilde@uzleuven.be
facility: 
contact: 
investigator: 
country: Belgium
responsible party type: Sponsor
mesh term: Glaucoma