A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
Overview
- Phase
- Not Applicable
- Intervention
- CorNeat KPro
- Conditions
- Corneal Disease
- Sponsor
- CorNeat Vision Ltd.
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- Safety Assessment
- Status
- Suspended
- Last Updated
- last month
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged ≥ 21 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
- •Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
- •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;
- •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 or severely scarred conjunctiva in the target eye
- •End stage glaucoma or evidence of current uncontrolled glaucoma
- •History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis)
- •Active inflammation of the conjunctiva in one or both eyes
- •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
- •Ocular ischemic syndrome
Arms & Interventions
CorNeat KPro
Intraocular implantation of the CorNeat KPro
Intervention: CorNeat KPro
Outcomes
Primary Outcomes
Safety Assessment
Time Frame: Throughout 24 months post-op
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation
Secondary Outcomes
- Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline(Throughout 24 months post-op)
- Retention rate(24 months post-op)