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

M

michal roll

Status

Unknown

Conditions

Papilledema Associated With Increased Intracranial Pressure

Treatments

Device: Point of care ocular ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02992262
0487-16-TLV

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

Shirley Friedman, MD

Data sourced from clinicaltrials.gov

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