Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Canada285 participantsStarted 2025-08
Plain-language summary
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?
Who can participate
Age range50 Years – 99 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. Referral for a suspected GCA relapse.
✕. 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.
✕
What they're measuring
1
Diagnostic performance of ONSD to identify new-onset GCA
Timeframe: Baseline
2
ONSD in patients with and without GCA
Timeframe: Baseline
Trial details
NCT IDNCT05749094
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal