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CompletedNCT02361671Updated Aug 28, 2023

Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

An observational study in Elevated Intracranial Pressure (ICP), sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions. The ability to monitor ICP is a crucial aspect in the management of these patients. Currently, the diagnosis of whether ICP is elevated or not is determined either with clinical signs (headache, nausea and vomiting or visual disturbances) or from the changes in the preoperative neuroimaging modalities such as computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).

Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD).

The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP.

Read the detailed description

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions. The ability to monitor ICP is a crucial aspect in the management of these patients. Currently, the diagnosis of whether ICP is elevated or not is determined either with clinical signs (headache, nausea and vomiting or visual disturbances) or from the changes in the preoperative neuroimaging modalities such as computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).

Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD).

The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP.

02

Conditions studied

  • Elevated Intracranial Pressure (ICP)
03

In context

Intracranial Hypertension

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

This study's enrollment of 100 is above the median of 60 across 80 observational studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Intracranial pathology patients scheduled for elective or emergency surgery.

Inclusion criteria

  • Intracranial pathology patients scheduled for elective or emergency surgery.
  • American Anesthesiologist Society physical status classification system (ASA) 1-4

Exclusion criteria

Exclusion Criteria:

  • history of Glaucoma,
  • previous retinal surgery,
  • optic neuritis,
  • lack of informed consent,
  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • OtherOptic Nerve Sheath Diameter using an ultrasound

    Optic nerve sheath diameter will be measured by ultrasound preoperatively on the day of surgery, Immediate postoperative period (within 24 hours) or 6-8 weeks after surgery on the follow-up visit.

06

What researchers measure

Primary outcomes

  1. Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve"

    Time frame: 6-8 weeks

07

Study locations

1 site
  • Toronto Western Hospital
    Toronto, Ontario M5T2S8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02361671
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Feb 12, 2015
Start date
Feb 2015
Primary completion
May 31, 2023
Completion
Jun 30, 2023
Last update
Aug 28, 2023

Study contacts

Dinsmore Michael, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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