Understanding how Giant Cell Arteritis affects vision

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enhance the understanding of how Giant Cell Arteritis (GCA) impacts visual health. By utilizing advanced imaging technologies such as High-resolution Optical Coherence Tomography and Angio-Optical Coherence Tomography, the study will compare ocular findings in patients with GCA-related visual impairment against those with non-arteritic causes. The goal is to improve diagnostic accuracy and predict patient outcomes based on the observed ocular manifestations. The study focuses on patients over 18 years old who either have confirmed GCA or acute visual impairment linked to GCA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For GCA group:

  * Patients older than 18 years with clinically suspected or confirmed gigantocellular arteritis.
  * Newly found visual involvement with suspected or confirmed correlation with vasculitis.
  * Ability to express valid consent to study enrolment.
* For control group:

  * Patients older than 18 years with the ability to express valid consent to study enrolment.
  * Newly diagnosed acute visual impairment with GCA phenotypes (e.g. AION, CRAO) but without any correlation with vasculitis aetiology.

Exclusion Criteria:

* Pre-existing ophthalmological pathologies that may modify best visual acuity and/or alter ophthalmological semeiotics.
* Concomitant active viral, bacterial, fungal and parasitic infections, including active or latent tuberculosis treated for less than 4 weeks and HIV, hepatitis C virus (HCV)

  /hepatitis B virus (HBV) infections, involving the eyes and orbital cavities.
* Concomitant systemic inflammations not attributable to GCA (inflammatory diseases in treatment-free remission are not excluded).
* Any other condition judged by the investigators to be a contraindication of eligibility

Where it's running

• ASST Fatebenefratelli-Sacco
  Milan, Lombardy, Italy Recruiting

Study contacts

• Principal investigator: Alessandro Invernizzi, Prof. — ASST Fatebenefratelli Sacco
• Study coordinator: Enrico Tombetti, Prof.
• Email: tombetti.enrico@asst-fbf-sacco.it
• Phone: 3289098793

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.