Ask to take part

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:

B Ilango 01902307999
balasubramaniam.ilango@nhs.net


Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

Recruiting

Open to: ALL

Age: 18.0 - 79.0

Medical Conditions

Keratoconus


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.


Cornea ectatic conditions such as keratoconus and post-LASIK (Laser In situ Keratomileusis) ectasia are disorders of the eye that are notorious for its uncontrolled progression over time, leading to loss of vision. There are valuable treatment options for controlling disease progression in mild to moderate stages of such disease. However in advanced cases and / or when contact lenses cannot be worn, surgery remains the only treatment option to rehabilitate vision. Most treatment options are highly invasive and represent significant risks. This study evaluates a novel corneal implant, Gebauer™ Lenticule to treat severe keratoconus or post-LASIK ectasia. This implant is derived from porcine collagen and intended for intra-stromal insertion. The Gebauer™ Lenticule is expected to improve the stability of the cornea while not impairing the vision. The procedure is an additive procedure after other treatment options have been exhausted. The procedure is reversible with removal of the implant (in the unexpected case of an adverse reaction), and vision may be restored to baseline.

The purpose of this study is to evaluate how well the implant is tolerated, it's safety profile, and how effective this new treatment option is in the treatment of keratoconus or post-LASIK ectasia.

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:

May 2024 Apr 2026

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : The Gebauer™ Lenticule corneal implant device is a custom-made device intended for patients suffering from keratoconus or post-LASIK ectasia. The device is expected to reinforce and stabilize the patient's cornea, so that a more consistent refraction is induced and a penetrating human cornea donor transplantation may be avoided or postponed.

Intervention Arm Group : Gebauer Lenticule;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


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

  • The Royal Wolverhampton NHS Trust
    Wolverhampton
    West Midlands
    WV10 0QP


The study is sponsored by The Royal Wolverhampton Hospitals NHS Trust and is in collaboration with Gebauer Company.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: NCT04741230
Last updated 02 January 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.