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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

DMS-15012

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 80 Years
All Sexes

Trial Timing

Ended 3 years ago

What is this trial about?

Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness

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