Health Condition 1: H540- Blindness, both eyes
Conditions
Interventions
Intervention1: CorNeat KPro: The CorNeat KPro is a patented synthetic corneal implant (keratoprosthesis) developed to provide a long-lasting medical solution for corneal blindness, pathology, and inju
Sponsors
CorNeat Vision Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 21 and = 80 years on the day of screening 2. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures 3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness – BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye 4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation 5. Indications that fall under poor candidate for keratoplasty include but are not limited to scarred cornea following transplantation failure, which can be either vascularized, limbal stem cell-deficient and/or following burn/trauma 6. Adequate tear film and lid function 7. Perception of light in all quadrants 8. Female patients of childbearing age must have a negative pregnancy test at screening and agree to use an effective method of contraception throughout the study
Exclusion criteria
Exclusion criteria: 1. Reasonable chance of success with traditional keratoplasty 2. Current retinal detachment 3. Connective tissue diseases or severely scarred conjunctiva in the target eye 4. End-stage glaucoma or evidence of current uncontrolled glaucoma 5. History or evidence of severe inflammatory eye diseases (i.e., conjunctivitis, uveitis, retinitis, scleritis) 6. Active inflammation of the conjunctiva in one or both eyes 7. History of ocular or periocular malignancy 8. History of extensive keloid formation 9. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device 10. Ocular ischemic syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The anatomical retention rate will be calculated and presented as the number of patients with retained device out of the total number of patients at the respective follow up visit. To clarify, anatomical retention refers to whether the device remains in place and intact within the eye. This will be evaluated by the presence or absence of complications such as device extrusion, endophthalmitis, or glaucoma.Timepoint: Throughout 24 months post-op | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Distant Visual Acuity will be determined using ETDRS visual acuity chart, where applicable, at each of the follow up visits throughout the trial’s duration and will be compared to that measured before KPro’s implantation. Additionally, if applicable, mean BCVA at each time point and the percentage of eyes with =6/120 vision will be calculated.Timepoint: Throughout 24 months post-op | — |
Countries
Canada, France, India, Israel, Netherlands, Peru
Contacts
Public ContactMala Srivastava
Nextvel Consulting LLP
Outcome results
None listed