First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness

CorNeat Vision

Status

Terminated

Conditions

Corneal Opacity

Corneal Disease

Corneal Injuries

Treatments

Device: CorNeat KPro

Study type

Interventional

Funder types

Industry

Identifiers

NCT04485858

DMS-15012

Details and patient eligibility

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

Full description

The objective of this clinical study is to prove the safety and effectiveness of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal blindness in subjects who are not candidates for traditional corneal transplant.

Ten subjects who are willing to take part in the study will undergo screening examinations to verify their eligibility.

The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures will be performed at 1 day, 1 week, 1, 2, 3, 6, 9 & 12 months post implantation and will include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be assessed and recorded throughout the 12 months follow up period.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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