Assessing the health of donor corneal cells before transplantation
Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
This study is testing a new way to check the health of donor corneal cells before transplanting them to see if it improves the success of the surgery for patients receiving them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Locations | 12 sites (Edegem and 11 other locations) |
| Trial ID | NCT05847387 on ClinicalTrials.gov |
What this trial studies
This international cohort study aims to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues intended for transplantation. The study will correlate the health of corneal endothelial cells, evaluated by the surgical team, with long-term functional and structural outcomes in patients receiving these tissues. The method involves using Trypan Blue, a vital dye, to independently assess endothelial cell viability, which is crucial for successful corneal graft function. This approach seeks to improve the accuracy of donor tissue evaluations and enhance transplantation outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for corneal transplantation due to conditions like keratoconus or Fuchs endothelial dystrophy.
Not a fit: Patients who have previously undergone corneal transplantation or those with certain ocular conditions, such as microbial keratitis or uncontrolled elevated intraocular pressure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing corneal transplantation by ensuring only viable donor tissues are used.
How similar studies have performed: While this approach is innovative, previous studies have indicated a poor correlation between traditional endothelial cell density assessments and actual tissue quality, suggesting a need for improved methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem and 11 other locations
- Antwerp University Hospital — Edegem, Belgium (Not_yet_recruiting)
- Department of Ophthalmology, University of Cologne — Cologne, Germany (Not_yet_recruiting)
- Münster University Hospital — Münster, Germany (Not_yet_recruiting)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia, Bs, Italy (Recruiting)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Not_yet_recruiting)
- Department of Medical and Surgical Sciences, University Magna Græcia — Catanzaro, Italy (Not_yet_recruiting)
- Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery — Roma, Italy (Not_yet_recruiting)
- Fondazione Banca degli Occhi del Veneto — Venice, Italy (Not_yet_recruiting)
- San Bortolo Hospital — Vicenza, Italy (Not_yet_recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Not_yet_recruiting)
- Hospital Regional Universitario de Málaga — Málaga, Spain (Not_yet_recruiting)
- Royal Liverpool University Hospital — Liverpool, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Vito Romano, MD — Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Study coordinator: Matteo Airaldi, MD
- Email: matteo.airaldi@unibs.it
- Phone: +390303995847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.