RecruitingOBSERVATIONAL

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

The V-CHECK study is looking for a better way to check the health of donor corneas before they are used for transplantation. When someone needs a corneal transplant, the cornea's inner layer, called the endothelium, is very important for keeping the eye clear. Currently, doctors estimate the health of these cells. This study is testing a new, simple method using a special dye to see if the cells are alive and healthy. If this new check works well, it could help surgeons choose the best corneas, leading to more successful transplants and clearer vision for longer for patients with conditions like corneal transplant failure or cell loss.

At a glance

Status

Recruiting

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Enrolment target

135

Start

01 Dec 2023

Estimated completion

30 Sep 2026

Corneal Transplant Failure Corneal Endothelial Cell Loss

What is this study about?

When someone needs a corneal transplant, part of the process involves using a donor cornea. Inside your cornea, there's a vital layer of cells called the endothelium. These cells act like tiny pumps, keeping your cornea clear by managing fluid. If these cells aren't healthy, your vision can become cloudy, leading to conditions like corneal transplant failure or corneal endothelial cell loss.

Currently, doctors mainly estimate the health of these cells by counting them under a microscope. While this count is helpful, it doesn't always tell the full story about whether the cells are truly working well. This study aims to fix that. Researchers have developed a new, simple method to directly check how healthy and 'viable' (alive and working) these important cells are in a donor cornea right before surgery. They use a special blue dye, which helps highlight any damaged or non-working cells.

The main goal of this study is to see if this new checking method, called V-Check, gives a better idea of how well the transplant will work in the long run. By using this dye to spot unhealthy areas, doctors hope to pick the best possible donor corneas. This could mean that more corneal transplants are successful, helping people to see clearly for longer after their surgery.

Key takeaways

Aims to predict corneal transplant success more accurately.
Uses a new dye-based method to assess donor cornea health.
Could lead to longer-lasting, clearer vision for transplant patients.
Focuses on improving donor cornea selection, not modifying your surgery.
Participation involves observation during and after your planned transplant.
Designed for patients undergoing specific types of corneal transplants.

Who may be eligible?

To join this study, you need to be at least 18 years old and be planning to have a specific type of corneal transplant surgery. This includes procedures like full-thickness corneal transplants (PK), or partial thickness transplants where only the inner layers are replaced (DSAEK, UT-DSAEK, or DMEK). You would also need to have certain conditions like keratoconus or Fuchs' endothelial dystrophy, which are considered to be at a low to moderate risk of your body rejecting the new cornea.

There are also some reasons why you might not be able to join. For example, if you’ve had a corneal transplant before, or if you're planning to have a specific type of 'preloaded' transplant. You also can't participate if your planned surgery doesn't involve transplanting the inner layer of the cornea, or if you have an active eye infection, severe inflammation, or uncontrolled high pressure in your eye.

Importantly, for all participants, you must be able to understand the study information and give your written consent to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for a corneal transplant like PK, DSAEK, UT-DSAEK, or DMEK?
Do you have a condition like keratoconus or Fuchs' dystrophy?
Have you NOT had a corneal transplant before?
Do you NOT have an active eye infection or severe eye inflammation?
Are you able to agree to take part after understanding the study?

Answer every question to see your result.

What does participation involve?

If you decide to join the V-CHECK study, the main part of your involvement will happen around your planned corneal transplant surgery. Before your surgery, the special V-Check dye will be used on the donor cornea to assess its health. This is part of the research – it's a new test being studied, not part of your standard care. After your surgery, the research team will follow up on your progress, likely measuring how well your new cornea is doing over time. This involves your regular post-transplant check-ups, where doctors will monitor your vision and the health of your new cornea. The study aims to compare the results of the V-Check method with your long-term outcomes to see if it predicts transplant success. The total duration of your participation will depend on how long the researchers need to track the success of your transplant, which often extends over several years.

Potential risks and benefits

Taking part in this study may offer benefits, as the findings could improve how donor corneas are selected, potentially leading to more successful transplants for future patients. However, this study primarily involves observation and a new assessment technique on the donor tissue, not a new treatment for you directly. There are no anticipated direct health risks to you from the V-Check dye exposure on the donor cornea, as it's a dye commonly used in surgery. As with any clinical study, you have the right to withdraw at any time without affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Antwerp University Hospital
Verified postcode
Edegem, Belgium· Not yet recruiting
Department of Ophthalmology, University of Cologne
Verified postcode
Cologne, Germany· Not yet recruiting
Münster University Hospital
Verified postcode
Münster, Germany· Not yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Verified postcode
Brescia, Italy· Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Verified postcode
Bologna, Italy· Not yet recruiting
Department of Medical and Surgical Sciences, University Magna Græcia
Verified postcode
Catanzaro, Italy· Not yet recruiting
Department of Experimental Medicine, Tor Vergata School of Medicine and Surgery
Verified postcode
Roma, Italy· Not yet recruiting
Fondazione Banca degli Occhi del Veneto
Verified postcode
Venice, Italy· Not yet recruiting
San Bortolo Hospital
Verified postcode
Vicenza, Italy· Not yet recruiting
Maastricht University Medical Center
Verified postcode
Maastricht, Netherlands· Not yet recruiting
Hospital Regional Universitario de Málaga
Verified postcode
Málaga, Spain· Not yet recruiting
Royal Liverpool University Hospital
Verified postcode
Liverpool, United Kingdom· Not yet recruiting

Common questions

What is the main goal of the V-CHECK study?

To find a better way to check the health of donor corneas before transplants to make them more successful.

Who can participate in this study?

Adults (18+) who are having certain types of corneal transplants for specific eye conditions like keratoconus or Fuchs' dystrophy.

What is 'V-Check'?

It's a new method using a special blue dye to directly look at how healthy the cells are in a donor cornea.

Will taking part change my surgery?

The V-Check method is applied to the donor cornea before your surgery, not to your eye directly during surgery. Your surgical procedure itself should not change.

What happens after my surgery in this study?

The researchers will follow your progress during your regular post-transplant check-ups to see how well your new cornea performs over time.

How to find out more

Matteo Airaldi, MD

matteo.airaldi@unibs.it +390303995847 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.