Visual Involvement in Giant Cell Arteritis
NCT Number: NCT06500728
Acronym: Visu-GCA
Status: RECRUITING
Study Type: OBSERVATIONAL
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|DIAGNOSTIC_TEST: High-resolution Optical Coherence Tomography|DIAGNOSTIC_TEST: Angio-Optical Coherence Tomography
Sponsor: ASST Fatebenefratelli Sacco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 762
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2030-06
Locations: ASST Fatebenefratelli-Sacco, Milan, Lombardia, 20157, Italy

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.

Primary Outcome Measures: Comparison of specific signs in A-AION vs. NA-AION and GCA-related CRAO vs. non-GCA-related., The primary outcome is a comparison of the frequency of the various semeiological findings by multi-parametric evaluation (visual field, fundus oculi, OCT, OCT-A, FAG, ICGA), among the main pathological ocular alterations of arteritic and non-arteritic aetiology, such as A-AION Vs. NA-AION and CRAO from arteritis Vs. CRAO from other causes., Since beginning of study for 6 years
Secondary Outcome Measures: Frequency of the pathological phenotypes of GCA visual involvement, A description of the prevalence of the GCA visual phenotypes, including the potential co-existence of several of them, for example, paracellular retinal ischemia as in PAMM, choroidal and papillary ischemia)., Since beginning of study for 6 years|Correlating the various clinical findings with different ophthalmological methods for each GCA ocular phenotype, at baseline., Integration of clinical findings at baseline with ophthalmological methods such as visual acuity, campimetry, FAG, ICGA, OCT, and OCT-A in various pathological visual conditions., At subject's enrollment|Correlating the various clinical findings with different ophthalmological methods for each GCA ocular phenotype, during follow-up, Integration of clinical findings during follow-up with ophthalmological methods such as visual acuity, campimetry, FAG, ICGA, OCT, and OCT-A in various pathological visual conditions., Since patient's enrollment for 6 months|Visual impairment evolution over time, analysing predictors of improved or worsened evolution., Temporal evolution of the visual acuity and semeiological findings after therapy and correlation with prognosis., Since patient's enrollment for 6 months
Other Outcome Measures: Identification of GCA biohumoral markers correlated with specific GCA ocular phenotypes, Since beginning of study for 6 years|Identification of GCA biohumoral markers correlated with visual prognosis, Since beginning of study for 6 years