Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

NCT05749094 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 285

Last updated 2025-08-07

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05749094 on ClinicalTrials.gov