Informations générales (source: ClinicalTrials.gov)
A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
Interventional
N/A
CorNeat Vision Ltd. (Voir sur ClinicalTrials)
juin 2024
mars 2026
22 août 2024
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Patrick Vachey | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Montpellier - 34295 - Montpellier - France | Hannah Croudy | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
2. Candidates must have the ability and willingness to attend all scheduled visits and
comply with all study procedures
3. 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
4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable
option or following a verifiable history of prior failed corneal transplantation.
5. 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;
6. Adequate tear film and lid function
7. Perception of light in all quadrants
8. Female patients of childbearing age must have negative pregnancy test at screening
and agree to use an effective method of contraception throughout the study.
1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
2. Candidates must have the ability and willingness to attend all scheduled visits and
comply with all study procedures
3. 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
4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable
option or following a verifiable history of prior failed corneal transplantation.
5. 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;
6. Adequate tear film and lid function
7. Perception of light in all quadrants
8. Female patients of childbearing age must have negative pregnancy test at screening
and agree to use an effective method of contraception throughout the study.
1. Reasonable chance of success with traditional keratoplasty
2. Current retinal detachment
3. Connective tissue diseases or severely scarred conjunctiva in the target eye
4. End stage glaucoma or evidence of current uncontrolled glaucoma
5. History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis,
uveitis, retinitis, scleritis)
6. Active inflammation of the conjunctiva in one or both eyes
7. History of ocular or periocular malignancy
8. History of extensive keloid formation
9. Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or
component of the device
10. Ocular ischemic syndrome
11. Signs of current infection, including fever and current treatment with antibiotics
12. Severe generalized disease that results in a life expectancy shorter than two years
13. Any clinical evidence that the investigator feels would place the subject at
increased risk with the placement of the device
14. 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
15. Currently pregnant or breastfeeding
16. 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
17. Intraoperative complication that would preclude implantation of the study device
18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes
and/or target organ damage associated with diabetes
19. Patients requiring anticoagulation treatment, which cannot be interrupted for the
surgical procedure
20. Vulnerable populations - minors, pregnant women, prisoners, sponsor or study
institution employees, military persons, terminally ill, comatose, physically and
intellectually challenged individuals, institutionalized patients and refugees
21. Subjects with corneal disorders located outside the central 7 mm, such as Mooren
ulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (if
located outside the central 7 mm of the cornea)
22. Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma
Surgery (MIGS) device that shunts aqueous from the anterior chamber into the
subconjunctival space