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

Recruitingn/aAges 18 Years - anyAllAzienda Socio Sanitaria Territoriale degli Spedal…
NCT05847387 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • V-Check
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Where

12 sites
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, 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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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