Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination
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|ClinicalTrials.gov Identifier: NCT02992262|
Recruitment Status : Unknown
Verified December 2016 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
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)|
|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|
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT02992262
|Contact: Shirley Friedman, MDfirstname.lastname@example.org|