Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Choroidal and Retinal Features in PACD and POAG on OCT and OCTA

Glaucoma is a group of irreversible, progressive optic neuropathies that can lead to severe visual field defects and even blindness, affecting nearly 95 million people worldwide. Based on anterior chamber angle structure, glaucoma is classified into primary angle-closure glaucoma (PACG) and primary open-angle glaucoma (POAG). Although POAG is more common, PACG is more severe and more likely to cause blindness if not managed appropriately. Globally, PACG accounts for approximately 25% of all glaucoma cases but is responsible for roughly 50% of glaucoma-related blindness. Generally, the term "glaucoma" implies optic nerve damage; however, glaucomatous optic neuropathy may be absent in subacute and acute angle-closure glaucoma. Therefore, according to international consensus, primary angle-closure disease is categorized as PACD-encompassing primary angle-closure suspect (PACS), primary angle closure (PAC), and PACG-based on the extent of angle closure, intraocular pressure elevation, and optic nerve damage. With advances in ophthalmic imaging, an increasing array of diagnostic modalities has been applied to glaucoma diagnosis. Optical coherence tomography (OCT), which utilizes low-coherence light to display cross-sectional images of the retina in vivo, represents a rapid, non-invasive, and continuously evolving imaging method. Building upon OCT, OCTA has emerged as a novel imaging technique that allows non-invasive visualization and assessment of blood flow in individual retinal layers [5]. Existing OCT and OCTA research on glaucoma primarily focuses on the optic disc and macula of glaucoma patients, providing evidence of changes in the retinal nerve fiber layer, macular ganglion cell thickness, optic nerve head structure, and peripapillary and macular vasculature. Other studies have examined choroidal vascular architecture and thickness in glaucoma; previous findings from our research group also indicate that choroidal vascular density is significantly lower in eyes with POAG and PACG compared to normal eyes, while choroidal stromal area is significantly greater in PACG than in POAG eyes and normal controls. Further investigation into choroidal and retinal alterations in glaucoma is warranted. Consequently, the OCT and OCTA fundus characteristics of patients with PACD and POAG remain an area with unexplored unknowns. This study utilizes OCT and OCTA to observe the choroidal and retinal tissue structure and vascular hemodynamics in patients with PACD and POAG, aiming to comprehensively investigate structural changes in the glaucomatous fundus, broaden new research directions, and explore and supplement the understanding of glaucoma pathogenesis.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

132

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Guangdong
      • Guangzhou, Guangdong, Chine, 510060
        • Recrutement
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

This study includes an observation cohort of adults diagnosed with POAG or PACD and a control cohort of healthy adults without glaucoma. Eligible participants range in age from 18 to 90 years and have no history of confounding retinal or neurological diseases that would interfere with OCT/OCTA imaging assessment.

La description

Inclusion Criteria:

  • Control group: Healthy individuals with no history of ocular surgery, IOP < 21 mmHg, and CDR < 0.5 bilaterally without asymmetry
  • Observation group: Glaucoma specialist-confirmed diagnosis of POAG or PACD (per ISGEO staging: PACS/PAC/PACG)

Exclusion Criteria:

  • History of retinal or macular disease (e.g., AMD, DR, RVO, ERM)
  • Non-glaucomatous optic neuropathy (e.g., MS, NMO)
  • Poor OCT/OCTA image quality
  • Refusal to sign informed consent

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Control Group

Inclusion Criteria:

  1. Individuals undergoing routine physical examination, generally in good health, with no history of prior surgery.
  2. No use of glaucoma medications, no evidence of elevated intraocular pressure (IOP < 21 mmHg), no significant optic nerve head (ONH) asymmetry (cup-to-disc ratio difference < 0.2), and cup-to-disc ratio (CDR) < 0.5 in both eyes.
  3. Age between 18 and 90 years, inclusive; any gender.

Exclusion Criteria:

  1. Known history of retinal disease, including any condition involving macular degeneration (e.g., age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, viral retinitis, or epiretinal membrane).
  2. Optic nerve abnormalities other than glaucoma, such as those associated with neurological complications (e.g., Multiple Sclerosis, Neuromyelitis Optica).
  3. Poor quality of OCT or OCTA images obtained post-examination.
  4. Refusal to sign the informed consent form.
Observation Group

Inclusion Criteria:

  1. Confirmed diagnosis of Primary Open-Angle Glaucoma (POAG) or Primary Angle-Closure Disease (PACD) by a glaucoma specialist. The diagnosis of POAG is based on standard clinical criteria, specifically: presence of an open angle, glaucomatous optic neuropathy, current or past elevation of intraocular pressure, and visual field defects [10]. PACD cases are diagnosed and enrolled according to the clinical staging system of PACS, PAC, and PACG as established by the International Society of Geographical and Epidemiological Ophthalmology (ISGEO) .
  2. Age between 18 and 90 years, inclusive; any gender.

Exclusion Criteria:

  1. Known history of retinal disease, including any condition involving macular degeneration (e.g., age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, viral retinitis, or epiretinal membrane).
  2. Optic nerve abnormalities other than glaucoma, such as those observed in patients with neurological com

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Subfoveal choroidal thickness (μm)
Délai: Day 1
Subfoveal choroidal thickness (SFCT) is defined as the vertical distance between the outer border of the retinal pigment epithelium (RPE)/Bruch's membrane complex and the choroid-scleral junction directly beneath the fovea centralis. This measurement is obtained using a widefield swept-source OCT device, which enables enhanced depth imaging and high-resolution visualization of the choroid.The assessment is subsequently conducted by a masked, experienced grader using the integrated caliper tool. SFCT serves as a quantitative biomarker for choroidal structural changes associated with primary angle-closure disease (PACD) and primary open-angle glaucoma (POAG).
Day 1
Deviation of the horizontal watershed zone
Délai: Day 1
The deviation of the horizontal watershed zone (HWZ) is assessed by determining whether the HWZ is displaced superiorly or inferiorly relative to the fovea centralis. This evaluation is performed using 24 × 20 mm en face OCTA images acquired with a widefield swept-source OCTA device. All measurements are carried out with the device's built-in caliper tool by a masked, experienced grader. The HWZ deviation serves as a quantitative indicator reflecting alterations in choroidal venous outflow patterns.
Day 1

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Choroidal vascularity index (%)
Délai: Day 1
Choroidal vascularity index (CVI) is defined as the ratio of choroidal vascular volume to total choroidal volume within a designated region, expressed as a percentage, with higher values indicating greater vascular density. The measurement was performed on images acquired with a widefield swept-source OCTA deviceand assessed by a masked, experienced grader.
Day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 juillet 2024

Achèvement primaire (Estimé)

20 avril 2027

Achèvement de l'étude (Estimé)

20 avril 2027

Dates d'inscription aux études

Première soumission

16 avril 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

12 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2024KYPJ067

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner