Optic Nerve Sheath Diameter in Hypertensive Emergency

Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06286696

Acronym

OpticUS

Enrollment

375

Registered

2024-02-29

Start date

2024-11-01

Completion date

2026-12-01

Last updated

2024-10-09

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

Conditions

Hypertension, Hypertensive Emergency, Papilledema

Brief summary

This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.

Interventions

DIAGNOSTIC_TESTOptic Nerve Sheath Diameter

Point of care ultrasonography of the optic nerve sheath diameter

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥ 18 years old * Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of \> 200 millimetres of mercury (mmHg) systolic and/or \> 120 mmHg diastolic

Exclusion criteria

* Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible. * Primary neurological cause of hypertension: ischemic cerebrovascular incident

Design outcomes

Primary

Measure	Time frame	Description
Papilledema	2 years	Sensitivity of ONSD \> 5mm for diagnosis of papilledema

Secondary

Measure	Time frame	Description
Hypertensive retinopathy grade 3 & 4 combined	2 years	Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 & 4 combined
Hypertensive encephalopathy	2 years	Sensitivity/specificity of the ONSD for hypertensive encephalopathy
Rapid acting medications administered intravenously to lower the elevated blood pressure	2 years	Sensitivity/specificity of the ONSD for the need for rapid acting medications administered intravenously to lower the elevated blood pressure
Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve	2 years	Diagnostic characteristics for the presence of a bulging optic nerve disc and/or crescent sign for above mentioned diagnoses (papilledema, hypertensive retinopathy grade 3&4 combined, hypertensive encephalopathy, need for rapid acting intravenous medications to lower elevated bloodpressure).

Contacts

Primary ContactTessa Mulder, MD

t.a.mulder@lumc.nl+31 71 52 96151

Backup ContactMartijn Bauer, MD, PhD

m.p.bauer@lumc.nl+31 71 52 62381

Outcome results

None listed

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