Health Condition 1: H186- Keratoconus
Conditions
Interventions
Intervention1: XENIA: XENIA is a corneal implant made of natural corneal collagen of animal (porcine) origin, in stabilizing the keratoconic cornea. XENIA material, natural corneal collagen, has been
Sponsors
Mr Steffen Gebauer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of keratoconus 2. Visual Acuity with contact lenses must be better than or equal to 20/40 3. Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day 4. Patients will have a minimal corneal thickness of 350 microns 5. In terms of general health, patients must not have any illnesses posing an immediate threat to life 6. Patients must over 18 years of age 7. Patients contact lenses must have been removed at least one week prior to surgery for spft contact lenses and two weeks prior to surgery for hard lenses 8. Must be able to complete all study visits 9. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study specific tests or procedures are performed
Exclusion criteria
Exclusion criteria: 1. Prior corneal surgery in the keratoconus group 2. Corneal scarring 3. History of other ocular pathologies that will interfere with the treatment 4. Active infection of the cornea 5. Subject with history of neurotrophic cornea 6. Subject with history of persistent corneal erosion difficulties with epithelial growth i.e., re epithelization 7. Pregnancy and lactation 8. History of previous ophthalmologic surgery on the operative eye 9. Patients refusing to remove contact lenses one week before surgery for soft lenses and two weeks before surgery for hard lenses 10. Patients with amblyopia, VA less than 20/200 for the contralateral eye 11. Patients with corneal thickness of less than 350 microns 12. Patients with IOP of less than 10 mmHg or than than 21 mmHg 13. Patients with an uncooperative disposition 14. Subject who is currently participating or have participated in an investigational study, other than the study, within the past 60 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency and severity of all treatment- related adverse events, during and after implantation of the XeniaTM and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.Timepoint: Day 1, 3, 7, 14 Week 4, 8, 10, 12 Month 4, 5, 6, 8, 10, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Keratometry [Time Frame: 3 months] 2. Subjective corneal clarity 3. Measurement of Best Corrected Distance Visual Acuity (BCDVA)Timepoint: Time Frame: 3 months (Change in Keratometry) | — |
Countries
India
Contacts
Public ContactDr Pravin Krishna V
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
Outcome results
None listed