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Die klinische Studie NCT06527326 für Zentrale seröse Chorioretinopathie ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy 400

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Die klinische Studie NCT06527326 ist eine interventionsstudie zur Untersuchung von Zentrale seröse Chorioretinopathie und hat den Status offene rekrutierung. Die Studie startete am 27. Mai 2024 und soll 400 Teilnehmer aufnehmen. Durchgeführt von Second Affiliated Hospital, School of Medicine, Zhejiang University ist der Abschluss für 1. Juli 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. Juli 2024 aktualisiert.
Kurzbeschreibung
To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), we have observed in our clinical practice that CSC patients often experience chronic gastrointestinal issues. This observation has led us to hypothesize that CSC may be associated with gut dysbiosis. The Bifidobacterium genus is widely recognized as a beneficial gut bacterium, and numerous well-established Bifi...Mehr anzeigen
Offizieller Titel

the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy

Erkrankungen
Zentrale seröse Chorioretinopathie
Weitere Studien-IDs
  • 2024-0611
NCT-Nummer
NCT06527326
Studienbeginn (tatsächlich)
2024-05-27
Zuletzt aktualisiert
2024-07-30
Studienende (vorauss.)
2026-07-01
Geplante Rekrutierung
400
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
central serous chorioretinopathy
Bifidobacterium genus
the gut dysbiosis
Primäres Ziel
Grundlagenforschung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Experimentellreceiving Bifidobacterium supplements
Live Combined Bifidobacterium
the Bifidobacterium genus supplement
Placebo-Vergleichspräparatreceiving placebo
PLACEBO
Placebo
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Best Corrected Visual Acuity
BCVA is commonly assessed during eye exams to determine the effectiveness of vision correction and to evaluate the impact of eye conditions or diseases on vision.
through study completion, an average of one year
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Central Retinal Thickness (CRT)
Central Retinal Thickness is typically assessed using imaging techniques such as optical coherence tomography (OCT), which provides detailed cross-sectional images of the retina, allowing for accurate measurement of its thickness.
through study completion, an average of one year
the thickness of Subretinal Fluid (SRF)
Subretinal fluid can cause vision distortion and may require medical intervention to address the underlying condition and reduce fluid accumulation.
through study completion, an average of one year
the thickness of Choroid
Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC).
through study completion, an average of one year
Choroidal Vascular Index (CVI)
This is a ratio or index that quantifies the proportion of the choroid occupied by blood vessels compared to the total choroidal area. It provides a measure of the relative density of the choroidal vasculature.
through study completion, an average of one year
Choroidal Vascular Volume (CVV)
This measures the total volume of the choroidal blood vessels within a specific area of the choroid. It reflects the overall blood vessel density and the amount of blood flowing through the choroidal vasculature.
through study completion, an average of one year
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • Age 18 to 60 years
  • Diagnosis of acute central serous chorioretinopathy (CSC) (affected eye: ① FFA and ICGA showing typical CSC manifestations, ② presence of subretinal fluid (SRF) at the macular fovea, ③ disease duration ≤ 6 months)
  • Best Corrected Visual Acuity (BCVA): 53 to 86 letters
  • Other: No significant systemic diseases, signed informed consent, and able to commit to follow-up

  • Presence of significant systemic diseases
  • BCVA of 20/200 or worse
  • Presence of choroidal or retinal atrophy in the macular fovea of the affected eye
  • Presence of choroidal neovascularization (CNV), age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), diabetic retinopathy (DR), choroidal hemangioma, pigment epithelial detachment (PED), etc., in the affected eye
  • High myopia in the affected eye
Second Affiliated Hospital, School of Medicine, Zhejiang University logoSecond Affiliated Hospital, School of Medicine, Zhejiang University
Zentrale Studienkontakte
Kontakt: Weixin Zheng, master, +86 18888918935, [email protected]
Kontakt: Panpan Ye, doctor, +86 13806506267, [email protected]
1 Studienstandorte in 1 Ländern

Zhejiang

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hanzhou, Zhejiang, 310000, China
Panpan Ye, doctor, Kontakt, +86 13806506267, [email protected]
Weixin Zheng, master, Kontakt, +86 18888918935, [email protected]
Offene Rekrutierung