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