Corneal Transplant FailureV-CHECKNCT05847387
The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
An observational study of Corneal Transplant Failure and Corneal Endothelial Cell Loss, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 12 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplant Failure, Corneal Endothelial Cell Loss
- What is being tested?
- V-Check
- How many people
- 135 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 1 Dec 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing keratoplasty at participating referral cornea clinics
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 6 countries
Italy6 sites, 6 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Luigi Fontana, MD
Luigi Fontana, MD
- Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, BS, 25123
Matteo Airaldi, MD, +390303995847, matteo.airaldi@unibs.it
Matteo Airaldi, MD
- Not yet recruiting
Department of Medical and Surgical Sciences, University Magna Græcia
Catanzaro, 88100
Vincenzo Scorcia, MD
Vincenzo Scorcia, MD
- Not yet recruiting
Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery
Roma, 00133
Francesco Aiello, MD
Francesco Aiello, MD
- Not yet recruiting
Fondazione Banca degli Occhi del Veneto
Venice, 30174
Diego Ponzin, MD
Diego Ponzin, MD
- Not yet recruiting
San Bortolo Hospital
Vicenza, 36100
Pietro Viola, MD
Pietro Viola, MD
Germany2 sites, 2 recruiting
- Not yet recruiting
Department of Ophthalmology, University of Cologne
Cologne, 50937
Björn Bachmann, PhD
Björn Bachmann, PhD
- Not yet recruiting
Münster University Hospital
Münster, 48149
Lamis Baydoun, MD
Lamis Baydoun, MD
Belgium1 site, 1 recruiting
- Not yet recruiting
Antwerp University Hospital
Edegem, 2650
Sorcha Ni Dhubhghaill, MD
Sorcha Ni Dhubhghaill, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Maastricht University Medical Center
Maastricht, 6229
Mor Dickman, MD
Mor Dickman, MD
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
Marina Rodriguez Calvo de Mora, MD
Marina Rodriguez Calvo de Mora, MD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Royal Liverpool University Hospital
Liverpool, L7 8YE
Stephen B Kaye, MD
Stephen B Kaye, MD
About this study
Official title: Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
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.
Read the 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.
- Being tested
- V-Check
- Keywords
- Keratoplasty, Corneal endothelium, Eye Banking
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-CheckDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Keratoplasty group | Patients undergoing keratoplasty and their respective donor tissue Receives: Diagnostic Test: V-Check |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative
Secondary outcomes (6)
Correlation of TBPA to declared endothelial cell density (dECD)
Spearman's rank correlation coefficient of TBPA and declared Endothelial Cell Density (dECD) as provided by the Eye Bank supplying the tissue
Measured: Preoperative
Correlation of TBPA to declared endothelial mortality on corneal folds
Spearman's rank correlation coefficient of TBPA and declared Endothelial Cell mortality on corneal folds as provided by the Eye Bank supplying the tissue
Measured: Preoperative
Final ECD
Final ECD of transplanted corneas at 12 months
Measured: 1 year after enrollment
Rate of endothelial cell loss
Rate of change of ECD over the course of the entire follow-up
Measured: 1 year after enrollment
Incidence of endothelial graft failure
The occurrence of clinically definite corneal edema and/or need for endothelial keratoplasty due to endothelial failure
Measured: 1 year after enrollment
Relative risk of endothelial graft failure associated with TBPA
Calculation through a proportional hazard model of the relative risk of endothelial graft failure attributable to preoperatively measured TBPA
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Dec 2023
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Romano, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Vito Romano, MD, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847387
- Sponsor's protocol ID
- VC1
- Acronym
- V-CHECK
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD with appropriated anonymization of sensible data will be stored to a dedicated repository after completion of the study
Publications
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.
PubMed 37730252
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
- ClinicalTrials.gov ID
- NCT05847387
- Acronym / sponsor ID
- V-CHECK / VC1
- Keywords
- Keratoplasty, Corneal endothelium, Eye Banking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoplasty group | – | Diagnostic Test: V-CheckPatients undergoing keratoplasty and their respective donor tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing keratoplasty at participating referral cornea clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-CheckPreoperative 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 | Diagnostic test | Keratoplasty group |
Primary outcome
Trypan Blue Positive Areas (TBPA) percentage and Donor mortality
Time frame: Preoperative
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
6 secondary outcomes
Correlation of TBPA to declared endothelial cell density (dECD)
Time frame: Preoperative
Correlation of TBPA to declared endothelial mortality on corneal folds
Time frame: Preoperative
Final ECD
Time frame: 1 year after enrollment
Rate of endothelial cell loss
Time frame: 1 year after enrollment
Incidence of endothelial graft failure
Time frame: 1 year after enrollment
Relative risk of endothelial graft failure associated with TBPA
Time frame: Preoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 37730252Airaldi 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.
- Individual participant dataSharing planned: Yes. All collected IPD with appropriated anonymization of sensible data will be stored to a dedicated repository after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vito Romano, MD principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Transplant Failure and Corneal Endothelial Cell Loss, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Germany, Belgium, Netherlands, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Airaldi, MD (+390303995847, matteo.airaldi@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trypan Blue Positive Areas (TBPA) percentage and Donor mortality (time frame: Preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.