Actively Recruiting
The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2025-10-02
135
Participants Needed
12
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with low to moderate rejection risk such as keratoconus or Fuchs endothelial dystrophy
- Ability to provide written informed consent
You will not qualify if you...
- Prior corneal transplantation
- Planned preloaded DSAEK or preloaded DMEK
- Planned keratoplasty not involving corneal endothelium transplantation (e.g., superficial or deep anterior lamellar keratoplasty)
- Evidence of current microbial keratitis
- Evidence of non-infectious or autoimmune keratitis
- Impending or actual corneal perforation
- Uncontrolled elevated intraocular pressure
- Previous glaucoma surgery
- Acute or chronic inflammatory or infectious anterior segment uveitis
- Presence of an anterior chamber intraocular lens for phakic or aphakic eyes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Antwerp University Hospital
Edegem, Belgium, 2650
Not Yet Recruiting
2
Department of Ophthalmology, University of Cologne
Cologne, Germany, 50937
Not Yet Recruiting
3
Münster University Hospital
Münster, Germany, 48149
Not Yet Recruiting
4
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, BS, Italy, 25123
Actively Recruiting
5
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Not Yet Recruiting
6
Department of Medical and Surgical Sciences, University Magna Græcia
Catanzaro, Italy, 88100
Not Yet Recruiting
7
Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery
Roma, Italy, 00133
Not Yet Recruiting
8
Fondazione Banca degli Occhi del Veneto
Venice, Italy, 30174
Not Yet Recruiting
9
San Bortolo Hospital
Vicenza, Italy, 36100
Not Yet Recruiting
10
Maastricht University Medical Center
Maastricht, Netherlands, 6229
Not Yet Recruiting
11
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Not Yet Recruiting
12
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8YE
Not Yet Recruiting
Research Team
M
Matteo Airaldi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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