Prospective Investigators Initiated Study to Evaluate the Safety and Indicative Effectiveness of XeniaTM custom made ocular implant in subjects having Keratoconus

Mr Steffen Gebauer0 个研究点目标入组 5 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

Mr Steffen Gebauer