<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/NCT02992262</url>
  </required_header>
  <id_info>
    <org_study_id>0487-16-TLV</org_study_id>
    <nct_id>NCT02992262</nct_id>
  </id_info>
  <brief_title>Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination</brief_title>
  <official_title>Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>michal roll</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <brief_summary>
    <textblock>
      Pediatric emergency department (PED) physicians frequently encounter children with symptoms&#xD;
      that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP)&#xD;
      such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED&#xD;
      physician, is considered an essential modality for assessment of the optic disc and the&#xD;
      diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient&#xD;
      compliance, the ability to open the eyelids, the absence of opacities in the ocular media and&#xD;
      a sufficiently large pupillary aperture. Hence, different levels of PED physician training,&#xD;
      lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis&#xD;
      and severe photophobia may hinder direct fundoscopic evaluation.&#xD;
&#xD;
      In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic&#xD;
      examination. The investigators aim to evaluate the yield of optic disc height as measured&#xD;
      with ocular point of care ultrasound to detect optic disc swelling in comparison to&#xD;
      ophthalmologic examination as the gold standard.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">January 2018</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>The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.</measure>
    <time_frame>Up to 24h from inclusion or until hospital discharge if admitted</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Papilledema Associated With Increased Intracranial Pressure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point of care ocular ultrasound</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients from the PED,&#xD;
&#xD;
          -  Aged 0-18 years,&#xD;
&#xD;
          -  Who require funduscopic examination and referred to ophthalmologic evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid,&#xD;
&#xD;
          -  History of glaucoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shirley Friedman, MD</last_name>
    <phone>+972-3-6974612</phone>
    <email>shirleyfri@tlvmc.gov.il</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>michal roll</investigator_full_name>
    <investigator_title>Director, Research and development unit, Tel-Aviv Medical Center, Israel</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
    <mesh_term>Papilledema</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/NCT02992262
org study id: 0487-16-TLV
nct id: NCT02992262
lead sponsor: 
Pediatric emergency department (PED) physicians frequently encounter children with symptoms
      that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP)
      such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED
      physician, is considered an essential modality for assessment of the optic disc and the
      diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient
      compliance, the ability to open the eyelids, the absence of opacities in the ocular media and
      a sufficiently large pupillary aperture. Hence, different levels of PED physician training,
      lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis
      and severe photophobia may hinder direct fundoscopic evaluation.

      In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic
      examination. The investigators aim to evaluate the yield of optic disc height as measured
      with ocular point of care ultrasound to detect optic disc swelling in comparison to
      ophthalmologic examination as the gold standard.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.
time frame: Up to 24h from inclusion or until hospital discharge if admitted
intervention type: Device
intervention name: Point of care ocular ultrasound
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Shirley Friedman, MD
phone: +972-3-6974612
email: shirleyfri@tlvmc.gov.il
responsible party type: Sponsor-Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: michal roll
investigator title: Director, Research and development unit, Tel-Aviv Medical Center, Israel
mesh term: Intracranial Hypertension
mesh term: Papilledema