<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/NCT03275142</url>
  </required_header>
  <id_info>
    <org_study_id>170608-1</org_study_id>
    <nct_id>NCT03275142</nct_id>
  </id_info>
  <brief_title>Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining</brief_title>
  <official_title>Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Comprehensive EyeCare of Central Ohio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icare USA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Comprehensive EyeCare of Central Ohio</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>
      To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or&#xD;
      corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at&#xD;
      any time during an exam, without affecting other testing. This may improve office-flow and&#xD;
      spare patients from returning for another exam for additional testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Four sites will enroll fifteen subjects each. Individual sites will identify their patients&#xD;
      using numbers 1-15. The link to their identity will be stored in their records but will not&#xD;
      be forwarded to other investigators. Only the originating site will have the identity log&#xD;
      linking the participants to the study records. All patients over age 18 in the patient clinic&#xD;
      are eligible for inclusion. Staff members and employees may also participate. Following&#xD;
      informed consent, each patient will undergo visual acuity testing, keratometry readings by&#xD;
      IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein&#xD;
      using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare&#xD;
      tonometer will be used to check the intraocular pressure (IOP) on one eye only. The&#xD;
      investigator will be masked as to which eye will undergo applanation. Immediately following&#xD;
      the IOP check, corneal staining, topography and keratometry readings will be repeated. The&#xD;
      unchecked eye will serve as a control as there may be mild variations in topography or IOL&#xD;
      Master even without applanation. Following the repeated testing, the control eye will also&#xD;
      undergo applanation to document IOP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Only the Investigator will be interpreting outcomes. The technician/care provider will perform all testing and will mask the investigator to which eye tonometry was performed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstration of corneal stability post-applanation with the Icare tonometer.</measure>
    <time_frame>30 minutes</time_frame>
    <description>Demonstration that the Icare tonometer does not alter keratometry readings performed by IOL Master, topography performed by Pentacam HR, or corneal staining as evaluated at slit-lamp with fluorescence as compared to the Oxford Grading Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.</measure>
    <time_frame>10 minutes</time_frame>
    <description>Evaluation of average keratometric difference pre and post-tonometry with ICare via Pentacam HR and IOL Master.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cylinder differences pre and post-tonometry with ICare tonometer.</measure>
    <time_frame>10 minutes</time_frame>
    <description>Total cylinder differences pre and post-tonometry with ICare Tonometer via Pentacam HR and IOL Master.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in corneal staining pre and post-tonometry with ICare Tonometer.</measure>
    <time_frame>10 minutes</time_frame>
    <description>Difference in corneal staining pre and post-tonometry with ICare Tonometer as compared to the Oxford Scoring Scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Evaluation of Corneal Stability Post-applanation</condition>
  <arm_group>
    <arm_group_label>Icare Applanation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into &quot;study&quot; or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ICare Applanation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into &quot;study&quot; or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Icare tonometer</intervention_name>
    <description>Icare tonometry effects of keratometry readings, topography, and corneal staining to demonstrate that the Icare tonometer does not alter subsequent evaluation or testing. This would allow IOP testing to be performed by technical staff at any time during the examination process without affecting subsequent tests. A total of fifteen patients at each of four sites will be evaluated using Icare tonometers provided by Icare USA. The investigator will be masked as to which eye will undergo Icare tonometry. Both the study eye and the control eye will undergo pre-tonometry and post-tonometry testing; Keratometry readings, IOL master, Topography via Pentacam, and corneal staining with fluorescein using the Oxford scoring scale.</description>
    <arm_group_label>Icare Applanation</arm_group_label>
    <arm_group_label>No ICare Applanation</arm_group_label>
    <other_name>Icare</other_name>
    <other_name>applanation</other_name>
    <other_name>tonometry</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#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>Kenneth A Beckman, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Comprehensive EyeCare of Central Ohio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive EyeCare of Central Ohio</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only the originating site of study will have the identity log linking the participants to the study records.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03275142/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03275142/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>February 3, 2022</submitted>
    <returned>February 24, 2022</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/NCT03275142
org study id: 170608-1
nct id: NCT03275142
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or
      corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at
      any time during an exam, without affecting other testing. This may improve office-flow and
      spare patients from returning for another exam for additional testing.
Four sites will enroll fifteen subjects each. Individual sites will identify their patients
      using numbers 1-15. The link to their identity will be stored in their records but will not
      be forwarded to other investigators. Only the originating site will have the identity log
      linking the participants to the study records. All patients over age 18 in the patient clinic
      are eligible for inclusion. Staff members and employees may also participate. Following
      informed consent, each patient will undergo visual acuity testing, keratometry readings by
      IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein
      using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare
      tonometer will be used to check the intraocular pressure (IOP) on one eye only. The
      investigator will be masked as to which eye will undergo applanation. Immediately following
      the IOP check, corneal staining, topography and keratometry readings will be repeated. The
      unchecked eye will serve as a control as there may be mild variations in topography or IOL
      Master even without applanation. Following the repeated testing, the control eye will also
      undergo applanation to document IOP.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
masking description: Only the Investigator will be interpreting outcomes. The technician/care provider will perform all testing and will mask the investigator to which eye tonometry was performed.
measure: Demonstration of corneal stability post-applanation with the Icare tonometer.
time frame: 30 minutes
description: Demonstration that the Icare tonometer does not alter keratometry readings performed by IOL Master, topography performed by Pentacam HR, or corneal staining as evaluated at slit-lamp with fluorescence as compared to the Oxford Grading Scale
measure: Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.
time frame: 10 minutes
description: Evaluation of average keratometric difference pre and post-tonometry with ICare via Pentacam HR and IOL Master.
measure: Total cylinder differences pre and post-tonometry with ICare tonometer.
time frame: 10 minutes
description: Total cylinder differences pre and post-tonometry with ICare Tonometer via Pentacam HR and IOL Master.
measure: Difference in corneal staining pre and post-tonometry with ICare Tonometer.
time frame: 10 minutes
description: Difference in corneal staining pre and post-tonometry with ICare Tonometer as compared to the Oxford Scoring Scale.
arm group label: Icare Applanation
arm group type: Experimental
description: Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation.
arm group label: No ICare Applanation
arm group type: Active Comparator
description: Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation.
intervention type: Device
intervention name: Icare tonometer
description: Icare tonometry effects of keratometry readings, topography, and corneal staining to demonstrate that the Icare tonometer does not alter subsequent evaluation or testing. This would allow IOP testing to be performed by technical staff at any time during the examination process without affecting subsequent tests. A total of fifteen patients at each of four sites will be evaluated using Icare tonometers provided by Icare USA. The investigator will be masked as to which eye will undergo Icare tonometry. Both the study eye and the control eye will undergo pre-tonometry and post-tonometry testing; Keratometry readings, IOL master, Topography via Pentacam, and corneal staining with fluorescein using the Oxford scoring scale.
arm group label: Icare Applanation
arm group label: No ICare Applanation
other name: Icare
other name: applanation
other name: tonometry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth A Beckman, M.D.
role: Study Director
affiliation: Comprehensive EyeCare of Central Ohio
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Only the originating site of study will have the identity log linking the participants to the study records.
provided document: 
provided document: 
submitted: February 3, 2022
returned: February 24, 2022