About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Patients older than 18 years with the ability to express valid consent to study enrolment.
Disqualifiers
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)
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
Trial population
Consecutive adult patients presenting with transient or permanent visual impairment, with or without associated vasculitic pathology, at the emergency department or ophthalmology outpatient clinic.
Trial design
Cohort
Prospective
Treatments tested in this trial
Fluorescein and Indocyanine green Angiography
Diagnostic testThe 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).
High-resolution Optical Coherence Tomography
Diagnostic testThe 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).
Angio-Optical Coherence Tomography
Diagnostic testThe 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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.
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.
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.
Other outcomes
Identification of GCA biohumoral markers correlated with specific GCA ocular phenotypes
Identification of GCA biohumoral markers correlated with visual prognosis
Sponsors and contacts
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