<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/NCT03778190</url>
  </required_header>
  <id_info>
    <org_study_id>2018-419-Non-NSU Health</org_study_id>
    <nct_id>NCT03778190</nct_id>
  </id_info>
  <brief_title>Magnet for Corneal Foreign Bodies</brief_title>
  <official_title>The Use of a Magnet to Remove Corneal Foreign Bodies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kendall Healthcare Group, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nova Southeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kendall Healthcare Group, Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, interventional study to assess the effectiveness and safety of a&#xD;
      commercially available &quot;eye magnet&quot; to remove corneal foreign bodies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vast majority of corneal foreign bodies are metallic and thus are frequently&#xD;
      ferromagnetic. Consequently, it may be possible to use a magnet to remove most corneal&#xD;
      foreign bodies. There are commercially available products for removing corneal foreign&#xD;
      bodies, but there are no published studies assessing these devices.&#xD;
&#xD;
      This will be a prospective interventional study to assess the use of an eye magnet for the&#xD;
      removal of metallic corneal foreign bodies in the emergency department.&#xD;
&#xD;
      After the patient signs written, informed consent, the physician will attempt to remove the&#xD;
      corneal foreign body with the North by Honeywell 326734G Eye Magnet with Loop. If the&#xD;
      physician is unable to remove the corneal foreign body with the magnet, he or she may proceed&#xD;
      with standard care.&#xD;
&#xD;
      The treating physician will fill out a brief data collection form for each patient to track&#xD;
      various outcomes as discussed below.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Actual">November 11, 2019</completion_date>
  <primary_completion_date type="Actual">November 11, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Rate</measure>
    <time_frame>5 minutes.</time_frame>
    <description>The percentage of patients in whom the magnet successfully removed the foreign body.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epithelial Damage</measure>
    <time_frame>5 minutes</time_frame>
    <description>The percentage of patients in whom the amount of fluorescein uptake on exam was more after the procedure compared to before the procedure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Corneal Foreign Body</condition>
  <arm_group>
    <arm_group_label>Magnet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Corneal Foreign Body Removal</intervention_name>
    <description>An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.</description>
    <arm_group_label>Magnet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  present to the emergency department with a metallic corneal foreign body&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  have pacemakers or metallic facial implants&#xD;
&#xD;
          -  possible globe rupture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tony Zitek, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kendall Healthcare Group, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kendall Regional Medical Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>August 4, 2020</results_first_submitted>
  <results_first_submitted_qc>August 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 26, 2020</results_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</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>Eye Foreign Bodies</mesh_term>
    <mesh_term>Foreign Bodies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03778190/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Magnet</title>
          <description>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.&#xD;
Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Magnet</title>
          <description>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.&#xD;
Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Success Rate</title>
        <description>The percentage of patients in whom the magnet successfully removed the foreign body.</description>
        <time_frame>5 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnet</title>
            <description>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.&#xD;
Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate</title>
          <description>The percentage of patients in whom the magnet successfully removed the foreign body.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Epithelial Damage</title>
        <description>The percentage of patients in whom the amount of fluorescein uptake on exam was more after the procedure compared to before the procedure.</description>
        <time_frame>5 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnet</title>
            <description>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.&#xD;
Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.</description>
          </group>
        </group_list>
        <measure>
          <title>Epithelial Damage</title>
          <description>The percentage of patients in whom the amount of fluorescein uptake on exam was more after the procedure compared to before the procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Magnet</title>
          <description>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.&#xD;
Corneal Foreign Body Removal: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Tony Zitek</name_or_title>
      <organization>Kendall Regional Medical Center</organization>
      <phone>305-480-6602</phone>
      <email>zitek10@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03778190
org study id: 2018-419-Non-NSU Health
nct id: NCT03778190
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, interventional study to assess the effectiveness and safety of a
      commercially available "eye magnet" to remove corneal foreign bodies.
The vast majority of corneal foreign bodies are metallic and thus are frequently
      ferromagnetic. Consequently, it may be possible to use a magnet to remove most corneal
      foreign bodies. There are commercially available products for removing corneal foreign
      bodies, but there are no published studies assessing these devices.

      This will be a prospective interventional study to assess the use of an eye magnet for the
      removal of metallic corneal foreign bodies in the emergency department.

      After the patient signs written, informed consent, the physician will attempt to remove the
      corneal foreign body with the North by Honeywell 326734G Eye Magnet with Loop. If the
      physician is unable to remove the corneal foreign body with the magnet, he or she may proceed
      with standard care.

      The treating physician will fill out a brief data collection form for each patient to track
      various outcomes as discussed below.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success Rate
time frame: 5 minutes.
description: The percentage of patients in whom the magnet successfully removed the foreign body.
measure: Epithelial Damage
time frame: 5 minutes
description: The percentage of patients in whom the amount of fluorescein uptake on exam was more after the procedure compared to before the procedure.
arm group label: Magnet
arm group type: Experimental
description: The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.
intervention type: Procedure
intervention name: Corneal Foreign Body Removal
description: An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.
arm group label: Magnet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tony Zitek, MD
role: Study Director
affiliation: Kendall Healthcare Group, Ltd.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Eye Foreign Bodies
mesh term: Foreign Bodies
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 