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The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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
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