NCT05749094

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 285 (estimated)
• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

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?

Detailed description

SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).

Conditions

• Giant Cell Arteritis
• Anterior Ischemic Optic Neuropathy
• Optic Neuropathy, Ischemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Standardized GCA assessment	Clinical assesment, blood test review, temporal/axillary artery ultrasound

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-12-01
• Completion: 2029-03-01
• First posted: 2023-03-01
• Last updated: 2025-08-07

Locations

6 sites across 1 country: Canada