Actively Recruiting

Age: 18Years +
All Genders
NCT05847387

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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