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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Balasubramaniam Ilango
+44 (0)1902 695823
balasubramaniam.ilango@nhs.net


Study Location:

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Be Part of Research - Trial Details - Investigating the safety and improvement of vision for patients suffering from severe keratoconus or post LASIK ectasia after treatment with the Xenia corneal lenticule
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Investigating the safety and improvement of vision for patients suffering from severe keratoconus or post LASIK ectasia after treatment with the Xenia corneal lenticule

Recruiting

Open to: All Genders

Age: Adult

Wolverhampton Leicester

Medical Conditions

Severe keratoconus or post-LASIK ectasia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Keratoconus and post-LASIK ectasia are progressive disorders characterized by thinning and distortion of the cornea of the eye, causing it to bulge and leading to a loss of visual function (eyesight). There are various options available for improving sight in mild to moderate stages of the disorder such as using a type of contact lens. However, in cases of advanced stages, or if for some reason inability to wear contact lenses, no acceptable improvement of sight can be achieved with contact lenses. In such conditions surgery to correct the problem may be considered.

For the treatment of severe keratoconus and post-LASIK ectasia, several treatment options are available. However, in some people, the risk of complications or some of the treatments not working in the long-term seem higher or they may be associated with potential risks of infection, perforation, and other adverse reactions. Finally, if no other options are feasible or possible, transplantation of a human donor cornea might be possible. Again, this treatment is highly invasive and represents significant risks such as transplant rejection and a complete loss of vision.

Other ways have been considered for treatment such as just replacing a portion of the cornea including other types of implantable collagen to treat these conditions. Researchers are looking for such implants to stop the progression of the disease even in advanced stages, and to postpone or even avoid the need for corneal transplantation.

For the purpose of this study, an innovative corneal implant called the Gebauer™ Lenticule will be used to treat severe keratoconus or post-LASIK ectasia. The Gebauer™ Lenticule is a type of corneal implant, made from a substance called collagen from an animal. The Gebauer™ Lenticule implant is a disc-shaped piece of see-through, highly purified, and stable corneal collagen fibres from a pig. It will be implanted into the diseased eye and is expected to improve the stability of the cornea while not impairing the vision.

We currently would only consider to implant the Gebauer™ Lenticule after other treatment options have been exhausted. The procedure is reversible, as the implant can be removed in the unexpected case of an adverse reaction, and the initial vision from before the implantation can be restored. Due to the transparency of the cornea, the implant can be seen and inspected at all times, which is beneficial to check on it.

The purpose of this study is to look at how well the implant is tolerated, its safety, and how effective this new treatment option is in the treatment of keratoconus or post-LASIK ectasia. This is not a first-in-human study, but currently, the implant has only been used in a small number of patients (approximately 17) so it is still a very new treatment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jun 2025 31 Dec 2025

Before treatment with the GebauerTM Lenticule, the doctor will decide suitability to take part. The doctor will perform a detailed ophthalmological investigation. If the criteria are met and informed consent to participate in this study is given, the patient can participate. The length of study participation will be 6 months. In addition to that, up to 2 further long-term follow-up visits after 1 and 2 years are currently planned. All participants in the study will undergo the Gebauer™ Lenticule implantation. Participants will have a series of telephone and clinic follow-up visits where ophthalmic examination of the eye and Lenticule will take place.


Patients aged between 18 and 80 years old who have a diagnosis of severe keratoconus or post-LASIK ectasia and would prefer to avoid corneal transplant surgery or penetrating keratoplasty.

You can take part if:



You may not be able to take part if:


1. History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems2. Previous corneal transplantation or corneal implant in the designated eye3. Cataract with anticipated surgical intervention (IOL implantation) within 2 years4. Active inflammation and/or infection of the eye or the eyelid5. IOP <10 mmHg or >21 mmHg6. Professionally diagnosed and currently treated autoimmune diseases7. Current strong symptoms of any allergy8. History of major organ transplantation and/or current continuing immunosuppressive treatment9. History of blood transfusion within the last 12 months10. Currently participating or has participated in another investigational clinical study within the past 60 days11. Pregnancy and lactation


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • New Cross Hospital
    Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Optimax Laser Eye Clinic (leicester)
    171-173 Charles Street
    Leicester
    LE1 1LA

The Gebauer™ Lenticule has several advantages in treating keratoconus or post-LASIK ectasia as the Gebauer™ Lenticule corneal implant device is a custom-made device intended for patients suffering from keratoconus or post-LASIK ectasia. The GebauerTM Lenticule is a see-through, compatible corneal implant for humans. Treatment with the device is safe and this study will hopefully show the implant will stop the diseased cornea from getting worse, without impairing vision or pressure in the eye.

The risks associated with participation in this study are similar in nature and severity to those encountered with other corneal surgeries. These risks include anterior or posterior synchie; cornea abrasion and opacity; device detachment and requirement of further surgical manipulation; cornea thinning and perforation; intraocular pressure elevation due to procedure or steroids; infection; inflammation; cataract induction; retinal detachment; and device rejection.
In previous studies, 17 patients have received this treatment, and 90% patient satisfaction and stable and clear lenticules over a 6-month follow-up period were reported.
If the implant needs to be removed, for example, if the implant is not tolerable, the procedure is reversible and the initial vision from before the implantation can be restored. The potential risks involved in removing the device are the same as any other small-incision keratoplasty procedures. There are no known additional risks as sight will be restored.
The implant may be inserted immediately after the pocket creation or delayed up to several months later with confidence. The pocket created can be opened up and re-accessed safely several months following insertion. Re-opening and re-accessing the pocket is a relatively safe procedure within several months of the initial surgery, usually with no significant change to vision provided there were no other complications such as infection and inflammation to impact on vision. If the implant is removed, vision will most likely return to what it was before the initial surgery.

Mr Balasubramaniam Ilango
+44 (0)1902 695823
balasubramaniam.ilango@nhs.net



The study is sponsored by The Royal Wolverhampton NHS Trust and funded by Gebauer Medizintechnik GmbH.



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Read full details for Trial ID: ISRCTN17771283

Or CPMS 45845

Last updated 08 July 2025

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