- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07858591
Retinal Capillary Vessel Density and Foveal Avascular Zone Size in Patients With Psoriatic Arthritis: A Case-Control Study. (PsA-RETINA)
Evaluation of Retinal Capillary Vascular Structures and the Foveal Avascular Zone in Patients With Psoriatic Arthritis.
In terms of blood flow per unit of tissue, the retina is one of the tissues with the highest blood flow in the body. Parameters such as the thickness of the choroid layer, which plays a crucial role in maintaining normal eye function, the dimensions of the foveal avascular zone (FAZ) supplied by this layer, and retinal vascular networks can be measured using non-invasive methods. OCTA (Optical Coherence Tomography Angiography) is an imaging tool that enables the non-invasive assessment of retinal microvascular densities and the measurement of the foveal avascular zone's dimensions. Studies conducted to date indicate that retinal capillary vessels and the dimensions of the foveal avascular zone are affected in rheumatological diseases, especially associated with systemic inflammation. This study aims to compare retinal capillary vessel density and foveal avascular zone dimensions in patients with psoriatic arthritis against those in a healthy population and in patients with psoriasis who do not have psoriatic arthritis, utilizing the non-invasive method of optical coherence tomography angiography.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In terms of blood flow per unit of tissue, the retina is one of the tissues with the highest blood flow in the body. Non-invasive methods allow for the measurement of-and the detection of changes in-the thickness of the choroid layer (which plays a crucial role in maintaining normal eye function), the foveal avascular zone (nourished by this layer), and the retinal vascular networks. OCTA (Optical Coherence Tomography Angiography) is an imaging tool capable of non-invasively assessing retinal microvascular densities and measuring the dimensions of the foveal avascular zone. Retinal microvascular structures can be affected by systemic pathologies, including various eye diseases. In recent years, there has been growing evidence indicating that retinal vessel densities-as detected by OCTA-are significantly altered and the dimensions of the foveal avascular zone differ in patients with connective tissue diseases, vasculitis, and spondylitis. Psoriatic arthritis is a common chronic inflammatory disease characterized by both spondyloarthropathy and peripheral arthritis involvement. There is currently no data in the literature regarding the status of the choroidal vasculature-a highly perfused tissue-in patients with psoriatic arthritis or its relationship with disease activity. In this study, we aimed to compare retinal capillary density and foveal avascular zone dimensions among patients with psoriatic arthritis, patients with psoriasis, and healthy individuals using OCTA. The study will also compare findings between subgroups of psoriatic patients with and without concomitant spondylitis.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Koray Ayar, Associated Proffessor
- Numéro de téléphone: 1648 +90 224-2955000
- E-mail: ayarkoray@hotmail.com
Lieux d'étude
-
-
Yıldırım
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Bursa, Yıldırım, Turquie (Türkiye), 16130
- Recrutement
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
-
Contact:
- Koray Ayar
- Numéro de téléphone: 05325618450
- E-mail: ayarkoray@hotmail.com
-
Contact:
- Koray Ayar, Associated Proffessor (Dr.)
- Numéro de téléphone: 1648 +90 224-2955000
- E-mail: ayarkoray@hotmail.com
-
Chercheur principal:
- Koray Ayar, Associated Proffessor (Dr.)
-
Sous-enquêteur:
- Neslihan Parmak Yener, Associated Proffessor
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population consists of volunteers from among patients with psoriatic arthritis who are being followed at the study center's rheumatology clinic. The patient control group comprises volunteers diagnosed with psoriasis by a specialist dermatologist. Participants in the healthy control group are healthcare workers or patient companions matched for age and gender with the patient group and the patient control group.
La description
Inclusion Criteria:
- Volunteers diagnosed with psoriatic arthritis according to CASPAR criteria
- Volunteers diagnosed with psoriasis by a specialist dermatologist
- Hospital staff or patient companions with no chronic illnesses
Exclusion Criteria:
- Diabetes mellitus
- Cancer
- Pregnancy or lactation
- Chronic renal failure
- Glocome
- History of eye surgery
- History of eye trauma
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Psoriatic arthritis
Participants with psoriatic arthritis |
Vessel density of retinal superficial capillary plexus Vessel density of retinal deep capillary plexus Vessel density of retinal prepapillary capillaries FAZ essessment parameters |
|
Psoriasis
Psoriasis participants with no other known systemic inflammatory disease |
Vessel density of retinal superficial capillary plexus Vessel density of retinal deep capillary plexus Vessel density of retinal prepapillary capillaries FAZ essessment parameters |
|
Healthy controls
Patient companions or hospital staff with no known chronic illnesses |
Vessel density of retinal superficial capillary plexus Vessel density of retinal deep capillary plexus Vessel density of retinal prepapillary capillaries FAZ essessment parameters |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Retinal SCP, VD
Délai: 1 day
|
Vessel density of retinal superficial capillary plexus |
1 day
|
|
Retinal DCP, VD
Délai: 1 day
|
Vessel density of retinal deep capillary plexus |
1 day
|
|
Retinal RCP, VD
Délai: 1 day
|
Vessel density of retinal prepapillary capillaries |
1 day
|
|
FAZ parameters
Délai: 1 day
|
Foveal avasculary assessment parameters |
1 day
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024-TBEK 2026/09-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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