Severe keratoconus or post-LASIK ectasia Eye Diseases
Conditions
Interventions
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 wi
Sponsors
The Royal Wolverhampton NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Signs of immunological rejection during the post-implantation observation period measured using a slit-lamp microscope once between 1-3 days 2. Frequency and severity of all treatment-related adverse events, during implantation of the Gebauer™ Lenticule and throughout the post-implantation observation period measured from safety monitoring records once between 1-3 days, at 14, 28, 42, 56, 70, and 84 days, and at 3, 6, 12, and 24 months 3. Microscopic examination of the eye using a slit-lamp at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 4. Corneal topography measured using Sirius Scan at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 5. Corneal thickness measured using Sirius scan at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 6. Patient satisfaction with received treatments and outcome measured using the Patient Satisfaction Survey Questionnaire once between 1-3 days, at 14, 28, 42, 56, 70, and 84 days, and at 3, 6, 12, and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in intraocular pressure (IOP) during observation period measured using Goldmann Tonometry examination once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 2. Changes in corneal transparency and lenticule transparency during observation period measured using a slit-lamp microscope once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 3. Microscopic examination of the eye using a slit-lamp microscope at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 4. Vision measured using a Snellen/LogMar Chart at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 5. Inflammation of cornea or sclera during observation period measured using a slit-lamp microscope at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 6. Changes to the corneal epithelium during observation period measured using a slit-lamp microscope at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 7. Changes to the conjunctiva, iris/pupil, and lens during observation period measured using a slit-lamp microscope at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 8. Changes to ocular pain/discomfort during observation period measured using a slit-lamp microscope at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 9. Best-corrected visual acuity during the observation period measured using a Snellen/LogMar Chart at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 10. Investigator’s overall procedure evaluation measured using assessment of patient's unaided and best-corrected visual acuity at baseline, once between 1-3 days, at 28 days, and at 3, 6, 12, and 24 months 11. Suitability of pocket size measured using examination with operating microscope at day 0 12. Duration of surgical procedure measured using examination with operating microscope at day 0 13. Requirement of specific post-surgical meas | — |
Countries
England, United Kingdom
Outcome results
None listed