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RECRUITING
NCT05847387

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

Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

View on ClinicalTrials.gov

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.

Official title: Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

135

Start Date

2023-12-01

Completion Date

2026-09-30

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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

Locations (12)

Antwerp University Hospital

Edegem, Belgium

Department of Ophthalmology, University of Cologne

Cologne, Germany

Münster University Hospital

Münster, Germany

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, BS, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Department of Medical and Surgical Sciences, University Magna Græcia

Catanzaro, Italy

Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery

Roma, Italy

Fondazione Banca degli Occhi del Veneto

Venice, Italy

San Bortolo Hospital

Vicenza, Italy

Maastricht University Medical Center

Maastricht, Netherlands

Hospital Regional Universitario de Málaga

Málaga, Spain

Royal Liverpool University Hospital

Liverpool, United Kingdom