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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva
Cincinnati Eye Institute
Edgewood, Kentucky, United States
University of British Columbia
Vancouver, British Columbia, Canada
UHN - University Health Network
Toronto, Ontario, Canada
CHU de Montpellier
Montpellier, France
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC
Time frame: Throughout the 12 months follow up period
Secondary Effectiveness Endpoint - Improvement in BCDVA
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
Time frame: Throughout the 12-months post operation
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Hopital Fondation Adolphe de Rothschild
Paris, France
Rabin Medical Center - Beilinson
Petah Tikva, Israel
Amsterdam UMC - Location AMC
Amsterdam, Netherlands
Maastricht UMC+
Maastricht, Netherlands