CTRI/2021/04/033197
Active, not recruiting
未知
Prospective Investigators Initiated Study to Evaluate the Safety and Indicative Effectiveness of XeniaTM custom made ocular implant in subjects having Keratoconus
Mr Steffen Gebauer0 sites5 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mr Steffen Gebauer
- Enrollment
- 5
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
Trail with Corneal ImplantHealth Condition 1: H171- Central corneal opacityHealth Condition 2: null- Corneal Edema with No Visual PotentialCTRI/2019/07/020024Eye Yon Medical Ltd
Completed
Phase 1
A Phase 1 Investigator Initiated Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with Staphylococcus aureus InfectioChronic rhinosinusitisInfection - Other infectious diseasesInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12616000002482The Queen Elizabeth Hospital9
Not yet recruiting
Not Applicable
A Prospective Investigator-initiated Study to explore the optimal dose of lenalidomide in combination therapy for patients with Multiple Myeloma Featuring Renal DysfunctioKCT0009561The Catholic University of Korea, Seoul St. Mary's Hospital30
Completed
Not Applicable
Prospective Investigator Initiated Study to investigate Efficacy and Safety of cell-free Autologous Conditioned Serum (ACS) in reduced facial skin elasticity by womalack of facial skin elasticity by healthy volunteersDRKS00009259niversität HamburgFachrichtung Kosmetikwissenschaft21
Terminated
Not Applicable
Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study: Effectiveness of intensive long-term blood pressure lowering treatment, provided by a Triple Pill strategy, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage.ACTRN12618001677291The George Institute1