CorNeat Vision Ltd.
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
Corneal Disease
Corneal Opacity
Corneal Injuries
CorNeat KPro
Not Applicable
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 |
Estimated Enrollment : | 40 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness |
Actual Study Start Date : | March 2024 |
Estimated Primary Completion Date : | March 2025 |
Estimated Study Completion Date : | March 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: CorNeat KPro Intraocular implantation of the CorNeat KPro |
Device: CorNeat KPro |
Ages Eligible for Study: | 21 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of British Columbia
Vancouver, British Columbia, Canada, Neck thigh
Not yet recruiting
UHN - University Health Network
Toronto, Ontario, Canada, M5T 2S8
Recruiting
University of Montpellier
Montpellier, France, 34295
Recruiting
Adolphe de Rothschild Foundation Hospital
Paris, France, 4941492
Recruiting
Rabin Medical Center - Beilinson
Five pumpkins, Israel, 1105 AZ
Not yet recruiting
Amsterdam UMC - Location AMC
Amsterdam, Netherlands,