First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
Sponsored by CorNeat Vision Ltd.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Male or female aged ≥ 18 and ≤ 80 years on the day of screening
* Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
* Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation
* Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency
* Pseudophakia
* Adequate tear film and lid function
* Perception of light in all quadrants
* Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study
Exclusion Criteria
* Reasonable chance of success with traditional keratoplasty
* Current retinal detachment
* Connective tissue diseases
* End-stage glaucoma
* History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation
* History of ocular or periocular malignancy
* History of extensive keloid formation
* Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
* Signs of current infection, including fever and current treatment with antibiotics
* Severe generalized disease that results in a life expectancy shorter than a year
* Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
* Corneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operated
* Currently pregnant or breastfeeding
* Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
* Intraoperative complication that would preclude implantation of the study device
* Vulnerable populations
