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
Severe keratoconus or post-LASIK ectasia
Once the participant meets recruitment criteria, a Femtosecond Laser will be used to create a 3 mm stromal pocket. The Xenia Lenticule will be inserted intra-stromally via the 3 mm pocket. Patients will be treated with antibiotics and anti-inflammatory eye drops for 2 weeks and will be followed up at 1 day, 4 weeks, 3 months, 1 year, and 2 years, as well as with telephone consultations whenever needed. The participant will have regular clinical assessments to review the implant and condition of the eye, and will include: 1. Intraocular pressure (IOP) measurement 2. Best corrected visual acuity 3. Corneal transparency (slit lamp) 4. Lenticule transparency (slit lamp) 5. Photodocumentation of corneal status 6. Inflammation of cornea or sclera 7. Signs of immunological rejection 8. Central corneal thickness measurement (OCT) 9. Corneal topography (K-reading map) 10. Assessment of corneal epithelium 11. Assessment of conjunctiva 12. Assessment of iris/pupil 13. Assessment of Lens 14. Assessment of ocular pain 15. Assessment of patient satisfaction 16. Assessment of conjunctiva 17. Assessment of iris/pupil 18. Assessment of lens 19. Assessment of ocular pain 20. Assessment of patient satisfaction with treatments and outcome In addition to that, safety monitoring will be performed (recording of adverse events and medications).
1. Diagnosis of either of the following: 1.1. Severe keratoconus in patients who would prefer to avoid corneal transplant surgery/penetrating keratoplasty 1.2. Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery/penetrating keratoplasty. 2. Free of diagnosed terminal illnesses (life expectancy of ≥2 years) 3. Aged ≥18 years and <80 years 4. 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 5. Understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed 6. Able and willing to complete all study visits and comply with the study-specific requirements
1. History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems 2. Previous corneal transplantation or corneal implant in the designated eye 3. Cataract with anticipated surgical intervention (IOL implantation) within 2 years 4. Active inflammation and/or infection of the eye or the eyelid 5. IOP <10 mmHg or >21 mmHg 6. Professionally diagnosed and currently treated autoimmune diseases 7. Current strong symptoms of any allergy 8. History of major organ transplantation and/or current continuing immunosuppressive treatment 9. History of blood transfusion within the last 12 months 10. Currently participating or has participated in another investigational clinical study within the past 60 days 11. Pregnancy and lactation