Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
This research study, called 'CrossCornealVision', is investigating if a treatment called corneal crosslinking can help improve the success of corneal transplants. If you need a corneal transplant because of problem blood vessels in your eye, you might be interested. The study will compare patients who have the crosslinking treatment before their transplant with those who go straight to having the transplant. Researchers hope that by reducing these problem blood vessels beforehand, the new transplanted cornea will work better and last longer. The study is open to adults over 18 years old who need a full corneal transplant due to certain eye conditions.
At a glance
What is this study about?
This study is designed to see if a simple treatment, called corneal crosslinking, can make a positive difference for people needing a corneal transplant. If you have problem blood vessels in your eye that are causing issues and mean you need a new cornea, this study might be for you. The main idea is that by treating these blood vessels before the transplant, the new cornea might have a better chance of working well and lasting longer.
You might be wondering how it works. Corneal crosslinking uses a special liquid called riboflavin (which is a type of vitamin) combined with ultraviolet light. This helps to strengthen the cornea and, in this study, the aim is to reduce those unwanted blood vessels. The study will compare two groups: one group will have this crosslinking treatment a few weeks before their corneal transplant, and the other group will go straight to having their transplant without the pre-treatment.
Researchers will carefully follow all participants to see if the crosslinking treatment really does help the transplanted cornea survive better. This involves regular eye checks and assessments over up to two years after the transplant to track how everyone is doing.
Key takeaways
- This study aims to improve corneal transplant success.
- It uses a light treatment called corneal crosslinking before transplant.
- Specifically targets problematic blood vessels in the eye.
- Compares pre-treatment vs. no pre-treatment before transplant.
- Involves adults (18+) needing a full corneal transplant.
- Requires regular follow-up appointments for up to 2 years.
Who may be eligible?
To join this study, you must be 18 years or older and need a corneal transplant because of problem blood vessels in your eye. These blood vessels must cover at least two parts (quadrants) of your eye's clear front surface, called the cornea.
You also need to be able to fully understand and agree to take part, and be willing to attend all the study appointments. If you have issues in both eyes, only one eye will be included in the study. Having certain other medical conditions or allergies might mean you can't take part.
Things that would mean you can't join include having less than two quadrants of problem blood vessels, very thin corneas (unless it's in a specific area that will be replaced), active eye infections or swelling, or if you're allergic to the treatment chemicals. If you have certain other serious health problems or are in another clinical trial, you also wouldn't be able to participate.
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?
- Do you need a corneal transplant because of problem blood vessels in your eye?
- Do these blood vessels cover at least two parts of your eye's clear surface?
- Are you able to attend all study appointments and understand what's involved?
- Do you have any eye infections or very thin corneas (in specific areas)? (These might exclude you)
What does participation involve?
If you join this study, you'll first have a full eye check-up, including photographs and special scans of your eye. We'll also ask about your vision and how your eye condition affects your daily life, and note down any other medicines you take.
Then, you'll be randomly put into one of two groups. If you're in the 'treatment group', you'll have the corneal crosslinking treatment about 8 to 10 weeks before your corneal transplant. You'll have another check-up two weeks after this treatment to see how you're doing. If the treatment hasn't reduced the problem blood vessels enough, you might have it repeated. You'll then go on to have your corneal transplant.
If you're in the 'control group', you'll have your corneal transplant without the pre-treatment. Both groups will have regular follow-up eye checks at 3, 6, 12, 18, and 24 months after your transplant to see how your new cornea is doing. These follow-up appointments are similar to the usual care you'd receive after a transplant.
Potential risks and benefits
Locations (7)
- Augenklinik des Klinikums der Universität MünchenVerified postcodeMünchen, Germany· Recruiting
- University Hospital of Cologne, Centre for OphthalmologyVerified postcodeCologne, Germany· Recruiting
- Universitätsklinikum Düsseldorf, Klinik für AugenheilkundeVerified postcodeDüsseldorf, Germany· Recruiting
- Universitätsklinikum des Saarlandes, Klinik für AugenheilkundeVerified postcodeHomburg, Germany· Recruiting
- Charité - Universitätsmedizin Berlin, Klinik für AugenheilkundeVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum Freiburg, Klinik für AugenheilkundeVerified postcodeFreiburg im Breisgau, Germany· Recruiting
- Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin RostockVerified postcodeRostock, Germany· Recruiting
Common questions
What is a corneal transplant?
A corneal transplant is an operation to replace a damaged or diseased cornea (the clear front part of your eye) with a healthy cornea from a donor.
What is corneal crosslinking?
It's a treatment that uses special drops and UV light to strengthen the cornea and, in this study, targets problem blood vessels.
Will I know if I'm getting the crosslinking treatment?
Yes, this study is 'open', meaning both you and your doctors will know if you are receiving the crosslinking treatment or going straight to transplant.
How long will I be in the study?
You will be followed for up to 24 months (two years) after your corneal transplant.
What kind of checks will I have?
You'll have regular eye examinations, photographs, special scans, and checks on your vision and quality of life.
How to find out more
Claus Cursiefen, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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