Actively Recruiting
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
Led by The Royal Wolverhampton Hospitals NHS Trust · Updated on 2026-01-15
15
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
T
The Royal Wolverhampton Hospitals NHS Trust
Lead Sponsor
G
Gebauer Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of severe keratoconus or severe post-LASIK ectasia in patients preferring to avoid corneal transplant surgery
- Age 18 years or older and less than 80 years old
- Free of diagnosed terminal illnesses with life expectancy of at least 2 years
- Contact lenses removed at least one week before surgery for soft lenses or two weeks for hard lenses
- Understands study requirements and provides written informed consent
- Able and willing to complete all study visits and follow study requirements
You will not qualify if you...
- History or presence of ocular conditions that may interfere with surgery, including corneal epithelial problems
- Previous corneal transplantation or corneal implant in the designated eye
- Cataract requiring surgical intervention within 2 years
- Active inflammation or infection of the eye or eyelid
- Intraocular pressure less than 10 mmHg or greater than 21 mmHg
- Diagnosed and currently treated autoimmune diseases
- Strong current allergy symptoms
- History of major organ transplant or ongoing immunosuppressive treatment
- Blood transfusion within the last 12 months
- Participation in another investigational clinical study within the past 60 days
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
B
B Ilango
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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