Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
NCT05749094 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 285
Last updated 2025-08-07
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?
Conditions
- Giant Cell Arteritis
- Anterior Ischemic Optic Neuropathy
- Optic Neuropathy, Ischemic
Interventions
- 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
Sponsors & Collaborators
-
McGill University Health Centre/Research Institute of the McGill University Health Centre
collaborator OTHER -
Ciusss de L'Est de l'Île de Montréal
collaborator OTHER -
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
collaborator OTHER -
Mount Sinai Hospital, Canada
collaborator OTHER -
St. Joseph's Health Care London
collaborator OTHER -
Ottawa Hospital Research Institute
collaborator OTHER -
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
lead OTHER
Principal Investigators
-
Jean-Paul Makhzoum, MD · Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
Eligibility
- Min Age
- 50 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-31
- Primary Completion
- 2027-12-31
- Completion
- 2029-03-31
Countries
- Canada
Study Locations
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