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

NCT05847387 | Recruiting

• 1 other identifier: VC1
• Study Type: observational
• Target: 135
• Locations: 6 countries
• Sites: 12

Brief 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.

Conditions

Corneal Transplant Failure; Corneal Endothelial Cell Loss

Keywords

Keratoplasty; Corneal endothelium; Eye Banking

Outcome Measures

Primary Outcomes (1)

• Trypan Blue Positive Areas (TBPA) percentage and Donor mortality

  The comparison of the endothelial mortality of included donor corneas measured preoperatively (TBPA) and the overall endothelial mortality as declared by the eye bank providing the tissue

  Preoperative

Secondary Outcomes (6)

• Correlation of TBPA to declared endothelial cell density (dECD)

  Preoperative

• Correlation of TBPA to declared endothelial mortality on corneal folds

  Preoperative

• Final ECD

  1 year after enrollment

• Rate of endothelial cell loss

  1 year after enrollment

• Incidence of endothelial graft failure

  1 year after enrollment

Study Arms (1)

Keratoplasty group

Patients undergoing keratoplasty and their respective donor tissue

Diagnostic Test: V-Check

Interventions

V-Check DIAGNOSTIC_TEST

Preoperative analysis of endothelial tissue staining with vital dye (Trypan Blue 0.05%) and image analysis to identify the percentage of Trypan Blue Positive Areas, corresponding to dead endothelial cells and/or denuded areas of endothelium, in tissues destined to keratoplasty

Keratoplasty group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients undergoing keratoplasty at participating referral cornea clinics

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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (12)

Antwerp University Hospital

Edegem, 2650, Belgium

NOT YET RECRUITING

Department of Ophthalmology, University of Cologne

Cologne, 50937, Germany

NOT YET RECRUITING

Münster University Hospital

Münster, 48149, Germany

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, BS, 25123, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

NOT YET RECRUITING

Department of Medical and Surgical Sciences, University Magna Græcia

Catanzaro, 88100, Italy

NOT YET RECRUITING

Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery

Roma, 00133, Italy

NOT YET RECRUITING

Fondazione Banca degli Occhi del Veneto

Venice, 30174, Italy

NOT YET RECRUITING

San Bortolo Hospital

Vicenza, 36100, Italy

NOT YET RECRUITING

Maastricht University Medical Center

Maastricht, 6229, Netherlands

NOT YET RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

NOT YET RECRUITING

Royal Liverpool University Hospital

Liverpool, L7 8YE, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• Airaldi M, Zheng Y, Aiello F, Bachmann B, Baydoun L, Ni Dhubhghaill S, Dickman MM, Kaye SB, Fontana L, Gadhvi KA, Moramarco A, Rodriguez Calvo de Mora M, Rocha de Lossada C, Scorcia V, Viola P, Calza S, Levis HJ, Parekh M, Ruzza A, Ferrari S, Ponzin D, Semeraro F, Romano V. Preoperative surgeon evaluation of corneal endothelial status: the Viability Control of Human Endothelial Cells before Keratoplasty (V-CHECK) study protocol. BMJ Open Ophthalmol. 2023 Sep;8(1):e001361. doi: 10.1136/bmjophth-2023-001361.

  PMID: 37730252 DERIVED

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Vito Romano, MD

  Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Airaldi, MD

CONTACT

+390303995847; matteo.airaldi@unibs.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: December 1, 2023
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of study
• Access Criteria: Upon approval of individual sharing request

Locations

BE (1); NL (1); ES (1); GB (1); DE (2); IT (6)