Ultrasound of the eye nerve to help detect and track giant cell arteritis
Tests whether ultrasound of the optic nerve sheath helps diagnose and monitor giant cell arteritis.
Key facts
- Who runs it
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Where
- Canada7 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
- Status
- Recruiting
- People taking part
- 285 people, planned
- Started
- 9 Aug 2025
- Expected to end
- Mar 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Optic nerve sheath ultrasound
- Standardized GCA assessment
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people over 50 years old who are sent to a GCA clinic because doctors think they may have new giant cell arteritis (GCA). GCA is an inflammation of blood vessels. The trial tests whether an eye ultrasound can help find and follow GCA.
- Age
- Over 50 years (record lists 50 to 99 Years)
- Sex
- All sexes
- Disease stage
- Suspected, new-onset GCA. People sent in for a suspected return (relapse) of GCA cannot join.
- Earlier treatment
- People cannot join if they currently take steroid pills (glucocorticoids) for ≥ 14 consecutive days in the previous 30 days, or ≥ 7 consecutive days if they also had steroids through a vein in the previous 30 days. Current immunosuppressive therapy (conventional or biologic) is not allowed.
Main reasons for not taking part
- Sent in for a suspected GCA relapse
- Current steroid use beyond the limits set in the record
- Current conventional or biologic immunosuppressive therapy
- Past retinal, optic nerve or demyelinating disease, normotensive hydrocephalus, brain tumors, or conditions with raised pressure inside the skull
- Any condition that prevents the eye ultrasound or the eye exam (fundoscopy)
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- To be included in SONIC-GCA, participants must meet all the following criteria:
- Age > 50 years
- Referral to a GCA clinic for suspected, new-onset GCA
- Ability to understand and willingness to sign an informed consent form
- Willingness to comply with study visits and procedures
Who cannot take part
- Current use of systemic glucocorticoids, with the following duration at the baseline visit: ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days
- Current use of any conventional or biologic immunosuppressive therapy
- Known previous medical history of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors (benign or malignant), or any conditions associated with intracranial hypertension
- Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy
- An individual who meets any of these criteria will be excluded from SONIC-GCA:
- Referral for a suspected GCA relapse
Other criteria
- Our population of interest is patients referred from any settings for suspected, new-onset GCA
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 99 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions:
Read full original descriptionShow less
1. What is the performance of ONSD to identify patients with new-onset, active GCA? 2. Is ONSD useful for monitoring GCA relapses during follow-up? 3. What is the intra- and interobserver reliability of ONSD measurements? 4. Does ONSD differ between patients with and without GCA-related retinal findings?
The 2 groups in the trial
- GCA group
Ascertainment of GCA will occur 6 months after study inclusion and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive diagnostic test for GCA, including ultrasound of temporal arteries, temporal artery biopsy, cranial MRI or cranial PET; and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA. Study visits : Baseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)
Treatment: Optic nerve sheath ultrasound and Standardized GCA assessment
- Non-GCA group
Participants who do not meet the composite clinical test validation for GCA (above). Study visits : Baseline and Month 6 (phone follow-up)
Treatment: Optic nerve sheath ultrasound and Standardized GCA assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis
- Plain-language title
- Ultrasound of the eye nerve to help detect and track giant cell arteritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT05749094, who can take part
- Record updated
- 21 October 2026