Investigator initiated, prospective study of Xenia corneal lenticule
Research type
Research Study
Full title
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
IRAS ID
279594
Contact name
Balasubramaniam Ilango
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 29 days
Research summary
Cornea ectatic conditions such as keratoconus and post-LASIK 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 impant, Gebauer™ Lenticul to treat severe keratoconus or post-LASIK ectasia. This implant is derived from bovine 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.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0176
Date of REC Opinion
27 Jan 2021
REC opinion
Further Information Favourable Opinion