Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: ORIENT Study

Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: a Chinese Multicenter Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04981548

Enrollment

1000

Registered

2021-07-29

Start date

2021-11-06

Completion date

2023-11-30

Last updated

2023-07-25

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

Conditions

Ultrasonography

Keywords

optic nerve sheath diameter, intracranial pressure

Brief summary

This study aims to adopt a multi-center large sample size study to define (1) the normal range of Chinese ONSD; (2) ONSD diagnosis for patients with high intracranial pressure; (3) to analyze the correlation between ONSD and intracranial pressure.

Detailed description

The ONSD, transcranial Doppler parameters and baseline data of the normal intracranial pressure group and the enhanced intracranial pressure group (more than 200 mmH2O) .

Interventions

OTHERno intervention

no intervention

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

1. People requiring lumbar puncture testing due to brain trauma, intracranial infection, intracranial vascular disease, intracranial tumors, peripheral neuropathy for the raised intracranial pressure group. 2. Healthy people for the normal intracranial pressure group.

Exclusion criteria

1. eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma 2. People with poor temporal window penetration. 3. Patients who refuse to sign informed consent.

Design outcomes

Primary

Measure	Time frame	Description
The normal range of ONSD in healthy Chinese adults.	2021.8-2022.8	We will perform ONSD measurements with normal people by using ultrasound. We aim to establish the range for optic nerve sheath diameter (ONSD) in healthy Chinese adults. And the normal range of ONSD will be measured and reported.
determine the ONSD cut-off point for high intracranial pressure.	2021.8-2022.8	We will perform ONSD measurements with patients who was suspected high intracranial pressure rand enquiring lumbar puncture. We will analyze the correlation between ONSD and intracranial pressure. And ONSD cut-off point for evaluating high intracranial pressure will be reported.

Countries

China

Contacts

Primary ContactSibo Wang, PhD

wangsibo92@163.com15844008297

Outcome results

None listed

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