search
Back to results

Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination

Primary Purpose

Papilledema Associated With Increased Intracranial Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Point of care ocular ultrasound
Sponsored by
michal roll
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Papilledema Associated With Increased Intracranial Pressure

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consecutive patients from the PED,
  • Aged 0-18 years,
  • Who require funduscopic examination and referred to ophthalmologic evaluation.

Exclusion Criteria:

  • Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid,
  • History of glaucoma.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2016
    Last Updated
    December 13, 2016
    Sponsor
    michal roll
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02992262
    Brief Title
    Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination
    Official Title
    Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    michal roll

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Papilledema Associated With Increased Intracranial Pressure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Point of care ocular ultrasound
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Consecutive patients from the PED, Aged 0-18 years, Who require funduscopic examination and referred to ophthalmologic evaluation. Exclusion Criteria: Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid, History of glaucoma.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shirley Friedman, MD
    Phone
    +972-3-6974612
    Email
    shirleyfri@tlvmc.gov.il

    12. IPD Sharing Statement

    Learn more about this trial

    Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination

    We'll reach out to this number within 24 hrs