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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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

132

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Guangdong
      • Guangzhou, Guangdong, Cina, 510060
        • Reclutamento
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Subfoveal choroidal thickness (μm)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Choroidal vascularity index (%)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 luglio 2024

Completamento primario (Stimato)

20 aprile 2027

Completamento dello studio (Stimato)

20 aprile 2027

Date di iscrizione allo studio

Primo inviato

16 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024KYPJ067

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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