Status:
TERMINATED
First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
Lead Sponsor:
CorNeat Vision Ltd.
Conditions:
Corneal Disease
Corneal Opacity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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
Detailed 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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04485858
Start Date
January 3 2021
End Date
June 1 2023
Last Update
September 24 2024
Active Locations (8)
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1
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
2
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
3
UHN - University Health Network
Toronto, Ontario, Canada, M5T 2S8
4
CHU de Montpellier
Montpellier, France, 34295