A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
This clinical trial will assess the clinical safety and performance 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. 40 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, 2 weeks, 1, 2, 3, 4, 5, 6,8, 10,12,15,18,21 and 24 months post-surgery 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 24 months follow up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The optical component of the CorNeat KPro will be implanted into a circular disc of the cornea (as performed in standard penetrating keratoplasty surgery) and the skirt component will be embedded under a 360º conjunctival flap.
University of British Columbia
Vancouver, British Columbia, Canada
RECRUITINGUHN - University Health Network
Toronto, Ontario, Canada
NOT_YET_RECRUITINGCHU de Montpellier
Montpellier, France
Safety Assessment
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation
Time frame: Throughout 24 months post-op
Retention rate
The number of retained devices at the end of 24- months follow up period will be calculated
Time frame: 24 months post-op
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after
Time frame: Throughout 24 months post-op
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Hopital Fondation Adolphe de Rothschild
Paris, France
RECRUITINGRabin Medical Center - Beilinson
Petah Tikva, Israel
RECRUITINGAmsterdam UMC - Location AMC
Amsterdam, Netherlands
NOT_YET_RECRUITING