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

NCT05847387 · tracked via the Priya Life Science Germany 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

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)

Facility	City	Region	Status
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 Germany