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Status unknownNCT02992262Updated Dec 14, 2016

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

An interventional study of Point of care ocular ultrasound in Papilledema Associated With Increased Intracranial Pressure, sponsored by michal roll. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2016-12-14.

Sponsored by michal roll · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Papilledema Associated With Increased Intracranial Pressure
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In context

Intracranial Hypertension

185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.

This study's planned enrollment of 300 is above the median of 50 across 95 interventional studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

michal roll is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Interventions

  • DevicePoint of care ocular ultrasound
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What researchers measure

Primary outcomes

  1. 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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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02992262
Lead sponsor
michal roll
Responsible party
michal roll (Director, Research and development unit, Tel-Aviv Medical Center, Israel, Tel-Aviv Sourasky Medical Center) — Sponsor-investigator
First posted
Dec 14, 2016
Start date
Jan 2017
Primary completion
Jan 2018 (estimated)
Last update
Dec 14, 2016

Study contacts

Shirley Friedman, MD
Contact
shirleyfri@tlvmc.gov.il
+972-3-6974612
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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