RecruitingPHASE3INTERVENTIONAL

Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

This study is for people in the UK with keratoconus, an eye condition where the front of the eye (cornea) becomes thin and changes shape. A common treatment is called crosslinking, which helps strengthen the cornea. After this treatment, people can sometimes experience pain because the eye's outer layer is gently removed. Currently, pain is managed with eye drops and paracetamol. Researchers want to see if placing a special, natural covering called an amniotic membrane (Visio-AMTRIX) over the eye after crosslinking can help reduce pain and speed up healing. This membrane has properties that might help the eye recover. It's a 'Phase 3' study, meaning it’s a big trial to confirm how well this new approach works.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

TBF Genie Tissulaire

Enrolment target

116

Start

25 Nov 2024

Estimated completion

01 Nov 2025

Progressive Keratoconus

What is this study about?

This research is looking into a way to make a common eye treatment called crosslinking more comfortable and effective for people with keratoconus. Keratoconus is a condition where the clear front part of your eye, called the cornea, gradually gets thinner and bulges out. This can make your vision blurry and get worse over time. Crosslinking is a treatment that uses special eyedrops and UV light to strengthen the cornea and stop the condition from getting worse.

After crosslinking, the outer layer of the cornea (epithelium) is often gently removed to allow the treatment to work better. While very effective, this can sometimes lead to discomfort or pain during the healing process. Doctors currently manage this pain with artificial tears and common painkillers like paracetamol. This study is exploring if a different approach can make a difference.

Scientists are investigating whether placing a special kind of natural covering, called an 'amniotic membrane' (specifically Visio-AMTRIX), on the eye after crosslinking can reduce pain and help the eye heal more quickly. Amniotic membranes are very thin tissues, often used in eye care as they have natural healing and pain-relieving properties. The study aims to compare how people feel and how well their eyes heal with and without this special membrane, to see if it offers a real benefit.

Key takeaways

The study explores a new way to reduce pain and improve healing after crosslinking for keratoconus.
It compares standard care (healing lens) with a healing lens plus a special natural membrane.
Participation involves receiving standard crosslinking plus one of the two extra post-treatment options.
The goal is to enhance recovery for patients with progressive keratoconus.
It's a large-scale 'Phase 3' study, aiming to confirm effectiveness before wider use.

Who may be eligible?

This study is looking for both men and women between the ages of 18 and 65 who have been diagnosed with keratoconus that is getting worse. You would specifically need to be needing a treatment called accelerated conventional crosslinking for your condition. Your eye doctor would need to confirm that your keratoconus meets certain measurements of severity and thickness.

To join, you must be able to understand the study information and give your agreement to take part. You also need to be well enough, both physically and mentally, to answer questions about any pain you might feel after the treatment. You must also be registered with a social security system in France (your doctor can explain this if you're unsure).

There are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you've already had crosslinking or certain other eye surgeries like refractive surgery on either eye. People with certain serious medical conditions, mental health issues, or those taking specific long-term painkillers or steroids, would also not be able to participate. Having certain eye problems like severe dry eye, glaucoma, or a history of eye infections like herpes or chickenpox (shingles) in the eye would also exclude you. Lastly, if you are unable to give consent or are under specific legal protections, you would not be able 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 between 18 and 65 years old?
Has your eye doctor told you that your keratoconus is getting worse and you need crosslinking?
Are you able to agree to take part and fill out questionnaires about pain?
Are you NOT pregnant or breastfeeding?
Have you NOT had crosslinking or certain other eye surgeries on either eye before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your doctor will explain everything in detail. You will still receive the standard crosslinking treatment for your keratoconus. However, in this study, you would either receive a special healing contact lens alone, or the healing contact lens with the added amniotic membrane (Visio-AMTRIX). Which one you receive will be decided by chance, like flipping a coin.

During the study, you'll have specific check-ups and assessments to see how your eye is healing and to measure any pain you might experience. You would be asked to fill out questionnaires about your pain levels after the procedure. The total duration of your involvement in the study would include these follow-up visits. All procedures would be explained fully by your eye care team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as potentially experiencing less pain or faster healing after your crosslinking procedure, if the new method proves effective. However, there's no guarantee of direct personal benefit. As with any medical procedure, there are potential risks, which your doctor will discuss in detail, including any specific to the crosslinking procedure or the use of the amniotic membrane. You are free to withdraw from the study at any time, for any reason, without it affecting the care you receive outside of the study.

Locations (9)

CHU de Brest
Verified postcode
Brest, France· Recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
Assistance Publique - Hôpitaux de Marseille
Verified postcode
Marseille, France· Recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
CHU de Nantes
Verified postcode
Nantes, France· Not yet recruiting
Hôpital National de la Vision des Quinze-Vingts
Verified postcode
Paris, France· Recruiting
CHU de Saint-Etienne
Verified postcode
Saint-Priest-en-Jarez, France· Recruiting
Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France· Recruiting
CHU de Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is keratoconus?

Keratoconus is an eye condition where the clear front part of your eye (cornea) becomes thin and bulges outwards, causing blurry vision.

What is crosslinking?

Crosslinking is a treatment that uses special eye drops and UV light to strengthen the cornea and help stop keratoconus from getting worse.

What is an amniotic membrane?

It's a very thin, natural tissue that has healing and pain-relieving properties, sometimes used in eye care.

Will I know if I get the membrane or not?

No, it's decided by chance, like a lottery, so neither you nor your doctor will know which treatment you receive until after the study is complete, for fairness.

Will this study affect my standard care?

No, your crosslinking treatment will be performed as planned. This study is looking at an additional approach to help with healing and comfort afterwards.

How to find out more

Laurence BARNOUIN, MD

laurence.barnouin@tbf-lab.com 0472686909 Official trial record

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