RecruitingNot ApplicableNCT04741230

Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

Prospective, Investigator Initiated Feasibility Study to Evaluate the Safety, and Indicative Effectiveness of Gebauer™ Lenticules in Patients Suffering From Severe Keratoconus or Post LASIK Ectasia


Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Enrollment

15 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a corneal lenticule called the Xenia Corneal Lenticule as an alternative to corneal transplant surgery for people with severe keratoconus or post-LASIK ectasia. Keratoconus is a condition where the cornea (the clear front of the eye) progressively thins and bulges outward into a cone shape, causing distorted and blurry vision. Post-LASIK ectasia is a similar complication that can occur after laser eye surgery. In severe cases, a corneal transplant is usually the final option, but it is a major surgery with a long recovery. The Xenia lenticule is a small piece of donor corneal tissue that can be surgically inserted into the patient's cornea to strengthen and reshape it — potentially avoiding or delaying the need for full corneal transplantation. This study tracks vision outcomes, safety, and patient satisfaction over time. You may be eligible if: - You are between 18 and 79 years old - You have severe keratoconus or severe post-LASIK ectasia - You prefer to avoid corneal transplant surgery - You are generally in good health with a life expectancy of at least 2 years - You have removed contact lenses for at least 1 week (soft) or 2 weeks (hard) before surgery You may NOT be eligible if: - You have had a previous corneal transplant or corneal implant - You have other eye diseases that may affect the surgery - You have intraocular pressure outside the normal range (below 10 or above 21 mmHg) - You have active eye inflammation or infection - You are on immunosuppressive therapy - You have had a blood transfusion in the past 12 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGebauer Lenticule

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.


Locations(1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, United Kingdom

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NCT04741230


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