Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

Launched by THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST · Feb 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for severe eye conditions called keratoconus and post-LASIK ectasia. These conditions can cause the shape of the cornea (the clear front part of the eye) to become irregular, leading to vision problems. The trial is testing a new corneal implant, called the Gebauer™ Lenticule, which is made from a type of collagen found in pigs. The goal is to see how well this implant works in stabilizing the cornea and improving vision without causing additional problems. This treatment might be a good option for patients who want to avoid more invasive surgeries like corneal transplants.

To be eligible for this study, participants need to be between 18 and 80 years old and have a diagnosis of severe keratoconus or post-LASIK ectasia. They should not have any serious eye infections or other eye problems that could interfere with the treatment. Participants will need to stop wearing contact lenses for a short period before the procedure and will be asked to sign consent forms to show they understand the study. Throughout the study, participants can expect regular visits to monitor their progress and any effects from the implant. Importantly, if any issues arise, the implant can be removed, and vision may return to what it was before the procedure.

Gender

ALL

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