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RECRUITINGOBSERVATIONAL

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Our population of interest is patients referred from any settings for suspected, new-onset GCA. Who May Qualify: 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 willing to sign a consent form form. 4. Willingness to comply with study visits and procedures. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (6)

St-Joseph's Health Care London
London, Ontario, Canada
Sinai Health - Toronto
Toronto, Ontario, Canada
MUHC - McGill University
Montreal, Quebec, Canada
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
CIUSSS de l'Est-de-l'ile de Montreal
Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada