Investigator Initiated, Prospective Study of Xenia Corneal Lenticule (NCT04741230) | Clinical Trial Compass
RecruitingNot Applicable
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
United Kingdom15 participantsStarted 2024-05-15
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Immunological rejection by ophthalmic examination of Intraocular pressure, Best corrected visual acuity, Corneal and Lenticule transparency, Inflammation
Timeframe: 6 months
2
Treatment-related adverse events.
Timeframe: 6 months
3
Changes in corneal topography (central K-reading results)
Timeframe: 6 months
4
Central corneal thickness
Timeframe: 6 months
Trial details
NCT IDNCT04741230
SponsorThe Royal Wolverhampton Hospitals NHS Trust