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Clinical Trials/NCT02992262
NCT02992262
Unknown
Not Applicable

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

michal roll0 sites300 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Papilledema Associated With Increased Intracranial Pressure
Sponsor
michal roll
Enrollment
300
Primary Endpoint
The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
January 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
michal roll
Responsible Party
Sponsor Investigator
Principal Investigator

michal roll

Director, Research and development unit, Tel-Aviv Medical Center, Israel

Tel-Aviv Sourasky Medical Center

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.

Outcomes

Primary Outcomes

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

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