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Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

RecruitingNAAges 18 Years - 79 YearsAllThe Royal Wolverhampton Hospitals NHS Trust
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Gebauer Lenticule
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Where

1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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