First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of… (NCT04485858) | Clinical Trial Compass
TerminatedNot Applicable
First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
Stopped: Sponsor's decision
United States, Canada, France10 participantsStarted 2021-01-03
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
Timeframe: Throughout the 12 months follow up period