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

NCT02992262 | Unknown

• 1 other identifier: 0487-16-TLV
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Papilledema Associated With Increased Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Point of care ocular ultrasound DEVICE

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• michal roll: lead

MeSH Terms

Conditions

Papilledema

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Central Study Contacts

Shirley Friedman, MD

CONTACT

+972-3-6974612; shirleyfri@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Research and development unit, Tel-Aviv Medical Center, Israel

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 14, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Last Updated: December 14, 2016

Record last verified: 2016-12