NCT04741230 Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
| NCT ID | NCT04741230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Royal Wolverhampton Hospitals NHS Trust |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-05-15 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty OR * Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty * In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years). * Patients must be aged 18 years or over and less than 80 years old * Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses * Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed * Patient must be able and willing to complete all study visits and comply with the study-specific requirements Exclusion Criteria: * History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems * Previous corneal transplantation or corneal implant in the designated eye * Cataract with anticipated surgical intervention (IOL implantation) within 2 years * Active inflammation and/or infection of the eye or the eye lid * Patients with Intra Ocular Pressure (IOP) \<10 mmHg or \>21 mmHg * Professionally diagnosed and currently treated autoimmune diseases * Current strong symptoms of any allergy * History of major organ transplantation and/or current continuing immunosuppressive treatment * History of blood transfusion within the last 12 months * Subject who is currently participating or has participated in another investigational clinical study within the past 60 days Pregnancy and lactation
Contact & Investigator
B Ilango
PRINCIPAL INVESTIGATOR
The Royal Wolverhampton NHS Trust
Frequently Asked Questions
Who can join the NCT04741230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04741230 currently recruiting?
Yes, NCT04741230 is actively recruiting participants. Contact the research team at balasubramaniam.ilango@nhs.net for enrollment information.
Where is the NCT04741230 trial being conducted?
This trial is being conducted at Wolverhampton, United Kingdom.
Who is sponsoring the NCT04741230 clinical trial?
NCT04741230 is sponsored by The Royal Wolverhampton Hospitals NHS Trust. The principal investigator is B Ilango at The Royal Wolverhampton NHS Trust. The trial plans to enroll 15 participants.