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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992262
Enrollment
300
Registered
2016-12-14
Start date
2017-01-31
Completion date
Unknown
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papilledema Associated With Increased Intracranial Pressure

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.

Interventions

DEVICEPoint of care ocular ultrasound

Sponsors

michal roll
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Contacts

Primary ContactShirley Friedman, MD
shirleyfri@tlvmc.gov.il+972-3-6974612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026