Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
Germany
Department of Ophthalmology, University of Cologne
NOT_YET_RECRUITING
Cologne
Münster University Hospital
NOT_YET_RECRUITING
Münster
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NOT_YET_RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
RECRUITING
Brescia
Department of Medical and Surgical Sciences, University Magna Græcia
NOT_YET_RECRUITING
Catanzaro
Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery
NOT_YET_RECRUITING
Roma
Fondazione Banca degli Occhi del Veneto
NOT_YET_RECRUITING
Venice
San Bortolo Hospital
NOT_YET_RECRUITING
Vicenza
Netherlands
Maastricht University Medical Center
NOT_YET_RECRUITING
Maastricht
Spain
Hospital Regional Universitario de Málaga
NOT_YET_RECRUITING
Málaga
United Kingdom
Royal Liverpool University Hospital
NOT_YET_RECRUITING
Liverpool
Contact Information
Primary
Matteo Airaldi, MD
matteo.airaldi@unibs.it
+390303995847
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 135
Treatments
Keratoplasty group
Patients undergoing keratoplasty and their respective donor tissue
Related Therapeutic Areas
Sponsors
Leads: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia