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Clinical Trials in Spain / NCT05847387
Recruiting Observational

The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study

NCT05847387 · tracked via the Priya Life Science Spain tracker
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase
Observational
Started
2023-12-01
Last updated
2025-10-02

Condition(s) studied

Corneal Transplant FailureCorneal Endothelial Cell Loss

Investigational drug(s) / intervention(s)

V-Check

V-Check: Preoperative analysis of endothelial tissue staining with vital dye (Trypan Blue 0.05%) and image analysis to identify the percentage of Trypan Blue Positive Areas, corresponding to dead endothelial cells and/or denuded areas of endothelium, in tissues destined to keratoplasty

Study summary

The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age older than 18 years old * Planned corneal transplantation: perforating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty (DMEK) * Indication for corneal transplantation (low-moderate risk of rejection): keratoconus, Fuchs endothelial dystrophy * Ability to provide written informed consent. Exclusion Criteria: * Prior corneal transplantation * Planned preloaded DSAEK or preloaded DMEK * Planned keratoplasty not involving corneal endothelium transplantation (i.e., superficial/deep anterior lamellar keratoplasty) * Evidence of concurrent microbial keratitis * Evidence of non-infectious or autoimmune keratitis * Impending or frank corneal perforation * Uncontrolled, elevated intraocular pressure (IOP)- Previous glaucoma surgery * Acute or chronic inflammatory/infectious anterior segment uveitis * Presence of an anterior chamber intraocular lens (IOL) for phakic or aphakic purposes

Primary outcome measure(s)

  • Trypan Blue Positive Areas (TBPA) percentage and Donor mortality — Preoperative
    The comparison of the endothelial mortality of included donor corneas measured preoperatively (TBPA) and the overall endothelial mortality as declared by the eye bank providing the tissue

Trial sites (12)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Belgium Not Yet Recruiting
Department of Ophthalmology, University of Cologne Cologne Germany Not Yet Recruiting
Münster University Hospital Münster Germany Not Yet Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Brescia BS Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Not Yet Recruiting
Department of Medical and Surgical Sciences, University Magna Græcia Catanzaro Italy Not Yet Recruiting
Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery Roma Italy Not Yet Recruiting
Fondazione Banca degli Occhi del Veneto Venice Italy Not Yet Recruiting
San Bortolo Hospital Vicenza Italy Not Yet Recruiting
Maastricht University Medical Center Maastricht Netherlands Not Yet Recruiting
Hospital Regional Universitario de Málaga Málaga Spain Not Yet Recruiting
Royal Liverpool University Hospital Liverpool United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05847387 on ClinicalTrials.gov ↗ ← All trials in Spain