The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Recruiting now
Conditions studied: Corneal Transplant Failure, Corneal Endothelial Cell Loss
In brief
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.
Key facts
- Study ID
- NCT05847387
- Run by
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- People needed
- 135
- Starts
- 2023-12-01
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2025-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia, BS, Italy (enrolling)
- Department of Ophthalmology, University of Cologne — Cologne, Germany
- Münster University Hospital — Münster, Germany
- 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
- Antwerp University Hospital — Edegem, Belgium
- Royal Liverpool University Hospital — Liverpool, United Kingdom
Full record on ClinicalTrials.gov
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