Safety and Indicative Effectiveness of XENIA™ Lenticules
Research type
Research Study
Full title
Prospective, Post-Market Clinical Follow-Up Study to Evaluate Performance and Safety of Custom-Made XENIA™ Lenticules in Patients Suffering from Severe Keratoconus or Post-LASIK Ectasia.
IRAS ID
265837
Contact name
Jonathan E. Moore
Contact email
Sponsor organisation
GEBAUER MEDIZINTECHNIK GmbH
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Summary of Research
Keratoconus is a bilateral, progressive disorder characterized by ectasia and thinning of the cornea, causing compromised visual function. Keratoconus is a disease seen quite commonly with prevalence rates of about 1 in 2000. Post-LASIK ectasia is another similar condition where the cornea starts to bulge forwards at a variable time after LASIK, PRK, or SMILE corneal laser eye surgery. It is one of the most devastating complications after Laser In situ Keratomileusis (LASIK). Several of these patients will eventually need corneal transplantation due to the inability to arrest the progression or due to unsuitability for other treatments.
This study will investigate the XENIA™ Lenticule, a corneal implant that will be used to treat keratoconus and post-LASIK ectasia. The XENIA™ Lenticule is a corneal stromal implant, manufactured from collagen of animal origin. The Gebauer Lenticule is intended to be implanted in a patient’s cornea in order to change its thickness and/or to change the cornea’s anterior curvature and/or to replace defective, compromised or vacant stromal tissue. The XENIA™ Lenticule could potentially delay or even avoid highly invasive human corneal transplantation in these patients.
Therefore, the objectives of this study are to evaluate the safety and indicative effectiveness of the Gebauer™ Lenticule implanted in subjects suffering from keratoconus or post-LASIK Ectasia.
Men and women over 18 and less than 80 years old, suffering from keratoconus or post-LASIK ectasia, who meet the inclusion/ exclusion criteria and provided written Informed Consent will be enrolled in the study. This study will recruit 3-10 subjects at a single site.
Full ophthamological examination will be performed to evaluate the safety and indicative effectiveness of the XENIA™ Lenticule.Summary of Results
No patients were recruited and termination of the study was sought.REC name
HSC REC B
REC reference
19/NI/0207
Date of REC Opinion
3 Dec 2019
REC opinion
Further Information Favourable Opinion