Evaluation of Vitreous Modifications After Cataract Surgery (VitCat)
Assessment of Vitreous Changes Following Cataract Surgery
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Cataract surgery may induce anatomical and biomechanical changes within the vitreous body and at the vitreoretinal interface. However, the extent and characteristics of these modifications remain incompletely defined, particularly when assessed using high-resolution optical coherence tomography (OCT).
The aim of this study is to investigate structural changes in the vitreous and vitreoretinal interface occurring after cataract surgery through a standardized preoperative and postoperative spectral-domain OCT imaging protocol.
Patients with cataract scheduled for surgery will be considered for inclusion. Eligible participants must have OCT images of sufficient quality for reliable assessment and no evidence of posterior vitreous detachment (PVD) at baseline. Both preoperative and postoperative OCT imaging must be available for comparative analysis.
Standardized OCT acquisition will include the 18 Line R64 and AS Star 18 Line R16 imaging protocols using the Dream OCT platform. These scans will be used to assess the posterior vitreous, its relationship with the retinal surface, and any postoperative changes in vitreous morphology or vitreoretinal interface configuration.
Preoperative and postoperative images will be compared both qualitatively and quantitatively. The analysis will focus on identifying changes in the visibility, configuration, position, and attachment of the posterior vitreous structures, as well as any modifications of the vitreoretinal interface occurring following cataract surgery.
Patients will be excluded in the presence of factors that may interfere with accurate vitreous assessment or independently alter vitreoretinal anatomy. These include advanced cataract significantly compromising OCT image quality, pre-existing posterior vitreous detachment, previous vitreous hemorrhage, previous vitreoretinal surgery, prior intravitreal injections, retinal diseases affecting evaluation of the vitreoretinal interface, pathologic high myopia, and a history of ocular trauma or uveitis.
The primary objective is to quantitatively and qualitatively characterize postoperative changes in vitreous morphology and vitreoretinal interface features after cataract surgery. The study is intended to improve understanding of the early structural effects of cataract surgery on the vitreous and to determine whether OCT imaging can reliably document these postoperative modifications.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
Paris
-
Créteil, Paris, Frankrike, 94000
- Rekruttering
- Centre Hospitalier Intercommunal de Créteil
-
Ta kontakt med:
- Marco Pastore, MD, PhD
- Telefonnummer: +33 (0) 1 57 02 30 54
- E-post: marco.pastore@chicreteil.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Presence of cataract scheduled for surgery
- Adequate image acquisition quality
- Absence of posterior vitreous detachment (PVD)
- Availability of both preoperative and postoperative OCT imaging
Exclusion Criteria:
- Advanced cataract significantly compromising image quality
Presence of posterior vitreous detachment (PVD)
- History of vitreous hemorrhage
- Previous vitreoretinal surgery
- Previous intravitreal injections (IVT)
- Retinal diseases affecting vitreoretinal interface assessment
- Pathologic high myopia
- History of ocular trauma or uveitis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
No vitreous detachment
Patients scheduled for cataract surgery without posterior vitreous detachment
|
standard cataracte surgery
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration
Tidsramme: 4 weeks
|
Preoperative and postoperative OCT images will be compared to identify participants showing structural changes in the posterior vitreous or vitreoretinal interface, including changes in posterior hyaloid position, vitreoretinal attachment status, and the development of partial or complete posterior vitreous detachment (PVD).
Results will be reported as the number and proportion of participants presenting these postoperative changes.
|
4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 05072026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .