Visual Involvement in Giant Cell Arteritis

Summary

This observational study aims to enhance the description of the different ways Giant Cell Arteritis (GCA) affects vision. The latest technology and knowledge are used to improve how we diagnose and predict patient outcomes. GCA is the most frequent vasculitis, an inflammation of vessels, in older adults. It involves large and medium-sized arteries and causes ischemic alterations such as stroke and blindness, through damage of extracranial arteries.

The primary objective is to compare the frequency of the various ocular findings between the main alterations of arteritic and non-arteritic aetiology, such as Arteritic Anterior Ischemic Optic Neuropathy (A-AION) Vs. Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION) or Central Retinal Artery Occlusion (CRAO) from GCA Vs. from other causes, through a comprehensive clinical and instrumental evaluation.

Conditions

• Giant Cell Arteritis
• Visual Impairment
• Central Retinal Artery Occlusion
• Anterior Ischemic Optic Neuropathy
• Paracentral Acute Middle Maculopathy
• Posterior Ischemic Optic Neuropathy
• Retinal Ischemia
• Blindness
• Visual Disorder

Interventions

DIAGNOSTIC_TEST

Fluorescein and Indocyanine green Angiography

The ophthalmologist frequently recommends fluorescein (FAG) and indocyanine green angiography (ICGA) at baseline (T0) to evaluate retinal and choroidal vascularisation. They can be repeated also after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4) or 26 ± 2 weeks (T5).

DIAGNOSTIC_TEST

High-resolution Optical Coherence Tomography

The ophthalmologist often suggests performing HR-OCT initially (T0) to assess the width of the macula and optic nerve with potential signs of ischemic lesions in these areas. This assessment can also be repeated after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

DIAGNOSTIC_TEST

Angio-Optical Coherence Tomography

The ophthalmologist often suggests OCT-A at the beginning (T0) to assess the retinal and choroidal vascularization. These tests can also be done after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco

  lead OTHER

Principal Investigators

• Alessandro Invernizzi, Prof. · ASST Fatebenefratelli Sacco

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-27

Primary Completion

2028-06-30

Completion

2030-06-30

Countries

• Italy

Study Locations