Status:
RECRUITING
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
Lead Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Collaborating Sponsors:
Gebauer Company
Conditions:
Keratoconus
Post-Laser Retinal Condition
Eligibility:
All Genders
18-79 years
Phase:
NA
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04741230
Start Date
May 15 2024
End Date
April 1 2026
Last Update
January 6 2025
Active Locations (1)
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1
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP