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

NCT ID: NCT05847387

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-09-30

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.

Detailed Description

The corneal endothelium is responsible for preserving corneal transparency by maintaining a dynamic equilibrium of corneal stromal hydration. Corneal Endothelial Cells (CECs) health is approximated by evaluating the Endothelial Cell Density (ECD) of corneal tissues though specular biomicroscopy. ECD is a key determinant of long-term tissue survival after corneal transplantation, as corneal graft function is directly dependent on the number of viable CECs. However, ECD represents only an estimation of total corneal endothelial health and is a suboptimal proxy for future endothelial failure.

In the current chain of supply of donor corneal tissues, no independent evaluation of endothelial cell viability by the surgical team tasked with transplanting the donor corneal tissue is anticipated. The investigators have previously shown a poor correlation between ECD declared by the eye bank providing the tissue and tissue quality as assessed independently by a cornea surgeon performing the transplantation (unpublished data).

In this study, the investigators describe a simple method to independently evaluate the overall endothelial viability of donor corneal tissue which can be adopted both by eye banks before shipment and by the corneal surgeons before transplantation in the operating theatre. This method uses basic image analysis to assess the extent of endothelial cell death and/or denuded endothelial areas with the use of Trypan Blue, a vital dye commonly employed during corneal transplantation. Endothelial cell loss is visualized and quantified as Trypan Blue Positive Areas (TBPA).

The primary objective of this study is to quantify the extent of TBPA in the operating theatre before corneal transplantation and correlate it to overall donor mortality declared by the eye bank. Secondary objectives include the assessment of the correlation of TBPA with declared ECD and CECs mortality, on folds, as well as the longitudinal analysis of endothelial cell loss as a function of time from surgery and initial TBPA over a follow-up of 12 months, final ECD, incidence of graft failure, and risk of graft failure attributable to preoperative TBPA.

Conditions

Corneal Transplant Failure; Corneal Endothelial Cell Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Keratoplasty group

Patients undergoing keratoplasty and their respective donor tissue

V-Check

Intervention Type: 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

Interventions

V-Check

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Vito Romano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vito Romano, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Locations

Antwerp University Hospital

Edegem, , Belgium

Site Status: NOT_YET_RECRUITING

Department of Ophthalmology, University of Cologne

Cologne, , Germany

Site Status: NOT_YET_RECRUITING

Münster University Hospital

Münster, , Germany

Site Status: NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, BS, Italy

Site Status: RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: NOT_YET_RECRUITING

Department of Medical and Surgical Sciences, University Magna Græcia

Catanzaro, , Italy

Site Status: NOT_YET_RECRUITING

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

Roma, , Italy

Site Status: NOT_YET_RECRUITING

Fondazione Banca degli Occhi del Veneto

Venice, , Italy

Site Status: NOT_YET_RECRUITING

San Bortolo Hospital

Vicenza, , Italy

Site Status: NOT_YET_RECRUITING

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status: NOT_YET_RECRUITING

Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status: NOT_YET_RECRUITING

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

Belgium; Germany; Italy; Netherlands; Spain; United Kingdom

Central Contacts

Matteo Airaldi, MD

Role: CONTACT

matteo.airaldi@unibs.it

+390303995847

Facility Contacts

Sorcha Ni Dhubhghaill, MD

Role: primary

Björn Bachmann, PhD

Role: primary

Lamis Baydoun, MD

Role: primary

Matteo Airaldi, MD

Role: primary

matteo.airaldi@unibs.it

+390303995847

Luigi Fontana, MD

Role: primary

Vincenzo Scorcia, MD

Role: primary

Francesco Aiello, MD

Role: primary

Diego Ponzin, MD

Role: primary

Pietro Viola, MD

Role: primary

Mor Dickman, MD

Role: primary

Marina Rodriguez Calvo de Mora, MD

Role: primary

Stephen B Kaye, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 37730252 (View on PubMed)

Other Identifiers

VC1

Identifier Type: -

Identifier Source: org_study_id