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

Papilledema Associated With Increased Intracranial Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02992262
• Other study ID #: 0487-16-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 13, 2016
• Start date: January 2017

Study information

• Verified date: December 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Shirley Friedman, MD
• Phone: +972-3-6974612
• Email: shirleyfri[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intracranial Hypertension
• Papilledema
• Papilledema Associated With Increased Intracranial Pressure

Intervention

Device:
• Point of care ocular ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
michal roll

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.		Up to 24h from inclusion or until hospital discharge if admitted	No