Recruiting

ONSD

Sponsor:

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Code:

NCT05749094

Conditions

Giant Cell Arteritis

Anterior Ischemic Optic Neuropathy

Optic Neuropathy, Ischemic

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Optic nerve sheath ultrasound

Standardized GCA assessment

Study Details

Brief 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

Study ID

NCT05749094

Start date

Aug, 2025

Status verified date

Jul, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

285 participants

Anticipated

Interventions and Outcome Measures

Arms

GCA group

Ascertainment of GCA will occur 6 months after study inclusion and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive diagnostic test for GCA, including ultrasound of temporal arteries, temporal artery biopsy, cranial MRI or cranial PET; and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA.

Study visits :

Baseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)

Non-GCA group

Participants who do not meet the composite clinical test validation for GCA (above).

Study visits : Baseline and Month 6 (phone follow-up)

Interventions

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.

Standardized GCA assessment

Clinical assesment, blood test review, temporal/axillary artery ultrasound

Primary outcome measure

  • Diagnostic performance of ONSD to identify new-onset GCA [ Time Frame: Baseline ]
  • ONSD in patients with and without GCA [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Recruiting

Montreal, Quebec, Canada, H4J1C5

Contacts

Principal Investigator:

Jean-Paul Makhzoum, MD

More Information

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Last update posted

Aug 7, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal on 2025-08-07.