Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Cornea… (NCT05694247) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
Stopped: The study was voluntarily terminated by the sponsor following emerging safety findings, including device exposure associated with conjunctival retraction. Enrollment was halted to allow further evaluation and optimization of the device and procedure.
Canada, France, Israel15 participantsStarted 2024-06-27
Plain-language 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
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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