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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02992262
Recruitment Status : Not yet recruiting
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Papilledema Associated With Increased Intracranial Pressure Device: Point of care ocular ultrasound Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02992262

Contact: Shirley Friedman, MD +972-3-6974612

Sponsors and Collaborators
michal roll

Responsible Party: michal roll, Director, Research and development unit, Tel-Aviv Medical Center, Israel, Tel-Aviv Sourasky Medical Center Identifier: NCT02992262     History of Changes
Other Study ID Numbers: 0487-16-TLV
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases