Optic nerve sheath ultrasound: The patients are examined in a supine relaxed position. The probe is gently placed on the closed eyelid with a standard ultrasound gel and adjusted to a suitable angle to display the optic nerve entry into the eyeball. Measurements are done 3mm distal to the posterior aspect of the ocular globe. Ultrasosonographic 14L5 probe is used with a safe thermal index, mechanical index and intensity limit. All patients will also undergo a bedside fundoscopic examination. Official ophthalmology consultation will be requested in patients with visual symptoms or abnormal fundoscopy.
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:
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?
Eligibility
Sex
ALL
Min age
50 Years
Max age
99 Years
Healthy volunteers
No
Our population of interest is patients referred from any settings for suspected, new-onset GCA.
Inclusion criteria:
To be included in SONIC-GCA, participants must meet all the following criteria:
1. Age \> 50 years.
2. Referral to a GCA clinic for suspected, new-onset GCA.
3. Ability to understand and willingness to sign an informed consent form.
4. Willingness to comply with study visits and procedures.
Exclusion criteria:
An individual who meets any of these criteria will be excluded from SONIC-GCA:
1. Referral for a suspected GCA relapse.
2. 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.
3. Current use of any conventional or biologic immunosuppressive therapy.
4. 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.
5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
Primary outcome measure(s)
Diagnostic performance of ONSD to identify new-onset GCA — Baseline The primary outcome of SONIC-GCA is to determine the optimal ONSD cutoff for identifying GCA at the baseline visit and to assess its diagnostic performance, including sensitivity, specificity, positive and negative predictive values, and accuracy.
ONSD in patients with and without GCA — Baseline At baseline, ONSD measurements (in mm) of the left and right eyes of each participant will be recorded and used to calculate the mean ONSD for patients with and without GCA.
Trial sites (6)
Facility
City
Region
Status
St-Joseph's Health Care London
London
Ontario
Not Yet Recruiting
Sinai Health - Toronto
Toronto
Ontario
Not Yet Recruiting
MUHC - McGill University
Montreal
Quebec
Not Yet Recruiting
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal
Quebec
Recruiting
CIUSSS de l'Est-de-l'ile de Montreal
Montreal
Quebec
Not Yet Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke
Quebec
Not Yet Recruiting
More Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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