This clinical trial will assess the clinical safety and performance of the CorNeat KPro.
ID
Source
Brief title
Condition
- Anterior eye structural change, deposit and degeneration
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PThe frequency and severity of all Adverse Device-related Events (ADE) during
and following implantation will be calculated and compared to that described in
the literature for Standard of Care (SOC) for patients with corneal blindness
not amenable by standard keratoplasty which is described in the *Known
Potential Risks* section.(as detailed in the Investigator*s Brochure).
Secondary outcome
1. The anatomical retention rate will be calculated and presented as the number
of patients with retained device out of the total number of patients at the
respective follow up visit. To clarify, anatomical retention refers to whether
the device remains in place and intact within the eye. This will be evaluated
by the presence or absence of complications such as device extrusion,
endophthalmitis, or glaucoma.
Note: In case the implant needs to be replaced within first 3 months post
implantation and the new implant meets the retention goals this will be
considered as a successful case.
2. Best Corrected Distant Visual Acuity will be determined using ETDRS visual
acuity chart, where applicable, at each of the follow up visits throughout the
trial*s duration and will be compared to that measured before KPro*s
implantation.
Additionally, if applicable, mean BCVA at each time point and the percentage of
eyes with >=6/120 vision will be calculated.
Background summary
Corneal pathology is a leading cause of blindness worldwide with 20-30 million
patients in need of a remedy and around 2 million new
cases/year. The epidemiology of corneal blindness is complex and encompasses
injury and a wide variety of infectious, genetic, and
inflammatory eye diseases, which cause corneal scarring or opacity and lead to
functional blindness.
Current solutions for corneal blindness and disease include penetrating
keratoplasty (PKP; corneal transplantation), lamellar
keratoplasty (DMEK, DALK), and rarely keratoprosthesis (KPro; artificial cornea
implantation). Together, keratoplasty and to a much
lesser extent KPros address 5%-10% of global cases due to lack of tissue
availability, low graft survival rates and the fact that some
corneal blindness indications are not suitable for keratoplasty. Thus, there is
an ever-growing number of patients for whom there is no
suitable solution.
An artificial solution would solve many shortcomings of the current available
treatments and therefore alleviate the suffering of scores of
affected individuals, predominantly in the developing world.
So far, attempts at creating scalable KPros have failed. Whereas previous KPros
have integrated an artificial lens into a biological
substrate that was then implanted into the eye, the CorNeat KPro is entirely
synthetic, comprised of a microporous skirt that leverages
the subconjunctival space for integration.
Study objective
This clinical trial will assess the clinical safety and performance of the
CorNeat KPro.
Study design
A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the
Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment
of Corneal Blindness
Intervention
The CorNeat KPro will be implanted into the subject*s eye with the optic
component snapping into the patient*s trephined cornea then
sutured to the eye wall using 3 non-degradable sutures and the skirt component
will be placed under the conjunctiva that will be
repositioned to cover the skirt.
Study burden and risks
Taking part in this study poses some known risks such as glaucoma, Retro
Prosthetic Membrane (RPM), endophthalmitis, inflammatory
reaction around the implant, foreign body sensation, stromal melting, poor
post-operative visual quality, intra ocular bleeding, retinal
detachment, droopy eyelid.
There is some risk related to study procedures such as side effects of the
dilation and anesthetic drops and general anesthesia risks like
mouth or throat pain, injury to mouth or teeth, allergic reaction to anesthetic
etc.
The CorNeat KPro can provide visual rehabilitation for severely diseased
corneas at high risk for failure with traditional corneal
transplantation.
The CorNeat KPro may reduce the major risks that Keratoprosthesis surgery holds
such as corneal melt, elevation of intraocular
pressure and endophthalmitis. Moreover, implantation of CorNeat KPro may
provide the patients with improved visual quality as
compared to current solutions.
Hasheizaf 4
Raanana 4366411
IL
Hasheizaf 4
Raanana 4366411
IL
Listed location countries
Age
Inclusion criteria
1. Male or female aged >= 21 and <= 80 years on the day of screening
2. 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
3. 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: scarred cornea following transplantation
failure, which can be either vascularized, limbal stem cell deficient and/or
following burn/trauma
4. Adequate tear film and lid function
5. Perception of light in all quadrants
Exclusion criteria
1. Reasonable chance of success with traditional keratoplasty
2. Current retinal detachment
3. Connective tissue diseases
4. End stage glaucoma
5. History or evidence of severe inflammatory eye diseases, ocular or
periocular malignancy or extensive keloid formation
6. Any known intolerance or hypersensitivity to topical anaesthetics,
mydriatics, or component of the device
7. Signs of current infection, including fever and current treatment with
antibiotics
8. Severe generalized disease that results in a life expectancy shorter than a
year
9. Any clinical evidence that the investigator feels would place the subject at
increased risk with the placement of the device
10 Corneal thickness less than 400 or higher than 1,200 microns in any region
of the pachymetry map of the eye intended to be operated
11. Currently pregnant or breastfeeding
12. Participation in any study involving an investigational drug or device
within the past 30 days or 5 half-lives of the drug (whichever longer) or
ongoing participation in a study with an investigational drug or device
13. Intraoperative complication that would preclude implantation of the study
device.
14. Vulnerable populations.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05694247 |
| CCMO | NL84528.000.23 |