RecruitingNAINTERVENTIONAL

Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

This study is looking into a new treatment for severe eye conditions called keratoconus and post-LASIK ectasia. These conditions cause the front of the eye (cornea) to weaken and bulge, which can lead to poor vision. While there are treatments for milder cases, advanced stages or when contact lenses are no longer an option often leave surgery as the only choice. Current surgeries can be very involved. This study is testing a new type of implant, called the Gebauer Lenticule, which is made from natural pig collagen. It's designed to be inserted into the cornea to make it more stable, without harming vision. This approach is for those who have exhausted other treatments and want to avoid a full corneal transplant. The study will assess how well the implant is tolerated, its safety, and how effective it is in treating these conditions. It's also reversible, meaning it can be removed if needed.

At a glance

Status

Recruiting

Phase

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Enrolment target

Start

15 May 2024

Estimated completion

01 Dec 2026

Keratoconus Post-Laser Retinal Condition

What is this study about?

This study is investigating a new treatment for two eye conditions: keratoconus and something called 'post-LASIK ectasia'. Both conditions affect the cornea, which is the clear, front window of your eye. In simple terms, these conditions cause the cornea to become weak and bulge outwards, like a cone, which blurs your vision. They can get worse over time.

While there are effective treatments for milder cases, or if you can still wear contact lenses comfortably, more advanced stages often require surgery. Current surgical options can be quite invasive and come with significant risks. This study is testing a new, less invasive approach called the Gebauer Lenticule. It's a small implant, made from natural material (pig collagen), that's carefully placed inside your cornea. The idea is that this implant will help strengthen your cornea, making it more stable and potentially stopping the condition from getting worse, all without causing a loss of vision.

This treatment is being explored for people with severe keratoconus or post-LASIK ectasia who are trying to avoid a full corneal transplant. It's an additional treatment option that would be considered if other therapies haven't worked for you. A key advantage is that the procedure is reversible; if there were unforeseen problems, the implant could be removed, potentially returning your eye to its original state. The main purpose of this study is to see how well people tolerate this implant, to understand its safety, and to find out how effective it is as a new treatment option.

Key takeaways

This study is for severe keratoconus or post-LASIK ectasia.
It tests a new implant (Gebauer Lenticule) made from pig collagen.
The goal is to strengthen the cornea and improve stability.
It's an option for those wishing to avoid corneal transplants.
The implant is designed to be reversible, allowing for removal if needed.
The study will assess the implant's safety and effectiveness.

Who may be eligible?

This study is for adults aged 18 to 79 who have been diagnosed with severe keratoconus or severe post-LASIK ectasia, and who would prefer to avoid a full corneal transplant. You also need to be generally healthy and not have any serious illnesses that limit your life expectancy to less than two years.

There are also some specific requirements for your eyes. You'll need to stop wearing contact lenses at least one week (for soft lenses) or two weeks (for hard lenses) before the potential surgery. You also need to be willing to understand the study, provide your written permission to take part, and be able to attend all the required appointments and follow the study instructions.

However, you won't be able to join the study if you have other eye problems that could interfere with the treatment, or if you've previously had a corneal transplant or a similar implant in the eye being considered. You also can't participate if you have cataracts that will likely need surgery soon, an active eye infection or inflammation, or very high or very low eye pressure. People with certain serious medical conditions, such as some autoimmune diseases, a recent blood transfusion (within the last year), a major organ transplant, or those taking medications to suppress their immune system, are also excluded. Pregnant or breastfeeding individuals, or anyone who has taken part in another clinical study recently (within the last 60 days), also cannot 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 between 18 and 79 years old?
Do you have a diagnosis of severe keratoconus or severe post-LASIK ectasia?
Would you prefer to avoid a corneal transplant surgery?
Are you generally healthy with no major illnesses?
Can you temporarily stop wearing contact lenses before the procedure (at least 1-2 weeks)?
Have you *not* had a previous corneal transplant or implant in the affected eye?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a thorough eye examination to ensure you meet all the criteria. If eligible, you would undergo a surgical procedure to have the Gebauer Lenticule implant placed in your cornea. This is an additive procedure, meaning it adds to your eye's existing structure.

After the surgery, you would need to attend several follow-up visits with the study team. These visits are crucial for monitoring your eye's healing, checking how the implant is performing, and assessing your vision. The study will involve regular eye tests and check-ups to track your progress and any changes in your eye. The exact number and frequency of visits will be explained in detail before you agree to participate. You will not be taking any specific study medication, but your eyes will be closely monitored. The total duration of your participation in the study, including all follow-up appointments, will also be clearly communicated.

Potential risks and benefits

Participating in this study offers potential benefits, such as a chance to improve the stability of your cornea and potentially avoid a corneal transplant, which is a more invasive surgery. However, as with any medical procedure, there are potential risks, including the possibility of complications from the surgery or adverse reactions to the implant. The study aims to thoroughly evaluate these risks and benefits. If, at any point, you decide that participating is no longer right for you, you have the right to withdraw from the study without giving a reason, and this will not affect your future medical care.

Locations (1)

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

The Royal Wolverhampton NHS Trust
Verified postcode
Wolverhampton, United Kingdom· Recruiting

Common questions

What is keratoconus?

Keratoconus is an eye condition where your cornea (the clear front part of your eye) gradually thins and bulges outwards into a cone shape, blurring your vision.

What is post-LASIK ectasia?

This is a rare complication that can happen after LASIK eye surgery, where the cornea weakens and bulges, similar to keratoconus, causing vision problems.

What is a Gebauer Lenticule?

It's a new, small implant made from pig collagen designed to be placed inside your cornea to help strengthen it and make it more stable.

Is the procedure permanent?

No, the procedure is reversible. If needed, the implant can be removed, and your vision would likely return to how it was before the procedure.

Why is this study being done?

This study aims to find out how safe and effective this new implant is for people with severe keratoconus or post-LASIK ectasia who want to avoid a corneal transplant.

How to find out more

B Ilango

balasubramaniam.ilango@nhs.net 01902307999 Official trial record

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