<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/NCT04485897</url>
  </required_header>
  <id_info>
    <org_study_id>895689</org_study_id>
    <nct_id>NCT04485897</nct_id>
  </id_info>
  <brief_title>Self-monitoring of the Intraocular Pressure Versus Hospital-based Diurnal Monitoring</brief_title>
  <official_title>Can Self-monitoring of the Intraocular Pressure With the Icare HOME Make Hospital-based Diurnal Monitoring Redundant?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luzerner Kantonsspital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Luzerner Kantonsspital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a&#xD;
      group of diseases that lead to optic nerve damage and corresponding deterioration of the&#xD;
      visual field.&#xD;
&#xD;
      Elevated intraocular pressure remains the most important risk factor. Interestingly,&#xD;
      glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.&#xD;
&#xD;
      Recent studies suggest pressure peaks, which are missed under the current practice of spot&#xD;
      intraocular measurements during office hours. In order to detect pressure peaks diurnal&#xD;
      measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.&#xD;
&#xD;
      The primary study objective is to verify that self-tonometry at home can provide valuable&#xD;
      information when looking for pressure peaks in patients with glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 26, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.</measure>
    <time_frame>4 years</time_frame>
    <description>Statistical methods for analysis of continuous method comparison data will be applied. The primary goal is to quantify the extent of agreement between two methods (Intraocular pressure measurement in-hospital and at home) and determine whether they sufficiently agree to be used interchangeably.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>variance of diurnal intraocular pressure</measure>
    <time_frame>4 years</time_frame>
    <description>Quantitative evaluation of day to day variance of diurnal intraocular pressure measurement in an out-hospital setting in patients with open angle glaucoma, normal tension glaucoma and healthy controls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of daily activities</measure>
    <time_frame>4 years</time_frame>
    <description>Influence of daily activities (sports, alcohol and water intake) on intraocular measurements at home (questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of treatment</measure>
    <time_frame>4 years</time_frame>
    <description>Change of treatment due to intraocular pressure peaks during hospitalisation and/or measurements at home</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Intraocular Pressure</condition>
  <arm_group>
    <arm_group_label>icare HOME</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>icare HOME device (Icare Oy, Vanda, Finland)</intervention_name>
    <description>icare HOME device versus hospital based measurements</description>
    <arm_group_label>icare HOME</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Subjects aged 18 and older&#xD;
&#xD;
          -  Glaucoma patients and healthy controls&#xD;
&#xD;
          -  Best corrected visual acuity &gt;0.1&#xD;
&#xD;
          -  Astigmatism ≤ 3dpt.&#xD;
&#xD;
          -  Good compliance&#xD;
&#xD;
          -  Central corneal thickness (400-650μm)&#xD;
&#xD;
          -  Passed certification procedure (detailed description under: Measurements and&#xD;
             procedures)&#xD;
&#xD;
          -  Therapeutic regimen unchanged throughout the past 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ocular trauma&#xD;
&#xD;
          -  Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual&#xD;
             acuity &lt;0.1&#xD;
&#xD;
          -  Physical or mental disability interfering with self-tonometry (e.g. arthritis,&#xD;
             Parkinson's disease)&#xD;
&#xD;
          -  Dry eye disease&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#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_contact>
    <last_name>Raphael Fritsche, MD</last_name>
    <phone>0041 205 33 76</phone>
    <email>raphael.fritsche@luks.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cantonal Hospital of Lucerne</name>
      <address>
        <city>Lucerne</city>
        <zip>6004</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>self-monitoring</keyword>
  <keyword>intraocular pressure</keyword>
  <keyword>icare HOME</keyword>
  <keyword>rebound tonometry</keyword>
  <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/NCT04485897
org study id: 895689
nct id: NCT04485897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a
      group of diseases that lead to optic nerve damage and corresponding deterioration of the
      visual field.

      Elevated intraocular pressure remains the most important risk factor. Interestingly,
      glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.

      Recent studies suggest pressure peaks, which are missed under the current practice of spot
      intraocular measurements during office hours. In order to detect pressure peaks diurnal
      measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.

      The primary study objective is to verify that self-tonometry at home can provide valuable
      information when looking for pressure peaks in patients with glaucoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.
time frame: 4 years
description: Statistical methods for analysis of continuous method comparison data will be applied. The primary goal is to quantify the extent of agreement between two methods (Intraocular pressure measurement in-hospital and at home) and determine whether they sufficiently agree to be used interchangeably.
measure: variance of diurnal intraocular pressure
time frame: 4 years
description: Quantitative evaluation of day to day variance of diurnal intraocular pressure measurement in an out-hospital setting in patients with open angle glaucoma, normal tension glaucoma and healthy controls
measure: Influence of daily activities
time frame: 4 years
description: Influence of daily activities (sports, alcohol and water intake) on intraocular measurements at home (questionnaire)
measure: Change of treatment
time frame: 4 years
description: Change of treatment due to intraocular pressure peaks during hospitalisation and/or measurements at home
arm group label: icare HOME
arm group type: Experimental
intervention type: Device
intervention name: icare HOME device (Icare Oy, Vanda, Finland)
description: icare HOME device versus hospital based measurements
arm group label: icare HOME
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Raphael Fritsche, MD
phone: 0041 205 33 76
email: raphael.fritsche@luks.ch
facility: 
status: Recruiting
country: Switzerland
responsible party type: Sponsor
sharing ipd: No