Where will the CorNeat KPro clinical trials take place?
The CorNeat KPro clinical trials are planned for the end of 2019, initially in Canada and France, followed by Israel and the USA at the beginning of 2020, and finally in China later that year.
When will the CorNeat KPro be available for use?
The planned KPro launch is set for 2021, most likely during the second half of the year.
What will the selection criteria be for patients for the CorNeat KPro implantation?
Initially, the CorNeat KPro will be approved as a second-line treatment, i.e. only patients who lack a therapeutic alternative or have failed a corneal transplantation will be eligible for the procedure. Approval of the CorNeat KPro as a first-line treatment is a priority for CorNeat Vision and will follow shortly after the initial approval.
Would a person with Keratoconus be a candidate for the CorNeat KPro implantation?
Keratoconus patients are suitable candidates for corneal transplantation (keratoplasty) with positive long-term results. Therefore, they are not ideal candidates for primary implantation. Keratoconus will not be a hindrance in the CorNeat KPro implantation in any case of rejection of a transplant or other complications in corneal transplantation as a second-line treatment.
Would a person with a detached retina be a candidate for the CorNeat KPro implantation?
Such a patient would not be a good candidate as the CorNeat KPro does not address the pathological aspect of this condition. Such a patient can only benefit from a KPro implantation as an aesthetic aid.
Would a person with Glaucoma be a candidate for the CorNeat KPro implantation?
Glaucoma is not a contraindication for the CorNeat KPro implantation. Glaucoma should be taken into account when planning the surgery as adjunct procedures might be necessary to improve follow-up of the implantation to decrease the risk of progression of Glaucoma.
Would a person with severe dry eye be a candidate for the CorNeat KPro implantation?
Initially we will treat patients with some tear production. With the accumulation of experience, we will collect the necessary evidence to encourage surgeons to tackle the most challenging and arid ophthalmic patients, suffering from alkali chemical burn, Steven Johnson’s syndrome or ocular cicatricial pemphigus.
Would a person with Herpes Keratitis be a candidate for the CorNeat KPro implantation?
Yes, we believe that Herpes patients stand to gain a valid therapeutic modality, which is currently missing in the battery of clinical ophthalmic solutions.
Would a person with scarring cornea be a candidate for the CorNeat KPro implantation?
Scarred, opaque and/or vascularized corneas are excellent candidates for the CorNeat KPro.
Would a person who had laser correction surgery be a candidate for the CorNeat KPro implantation?
Yes, laser correction does not interfere with the CorNeat KPro implantation procedure.
Would a person who had a corneal transplantation (one or more) which was/were rejected be a candidate for the CorNeat KPro implantation?
Yes, patients with failed corneal grafts are our ideal candidates for implantation
What are the differences between the CorNeat KPro and the Boston KPro?
1. The Boston KPro utilizes a donor cornea to attach the synthetic lens to the eye. The bond between the optic (artificial lens) and the donor cornea erodes with time creating hypotonicity and a port of entry to bacteria leading usually to loss of the eye. In most areas of the world, tissue is scarce and procedural knowledge of corneal transplantation limits the scalability of the procedure. The CorNeat KPro is completely synthetic and in animal implantations the bond between device and tissue has been shown to be strong and long-lasting. The CorNeat KPro is an off-the-shelf device, i.e. scalable.
2. The Boston KPro provides a narrow field of view both for the patient and physician. This limits the ability of the practitioner to follow up on the eye’s health and intervene in time. The CorNeat KPro has a wide field of view similar to a true cornea. This will allow regular and thorough follow up, provide the patient with real-life optics and maintain an aesthetic appearance.
3. The Boston KPro is a temporary solution, which needs to be replaced within a few years or it fatally damages the eye's visual potential through a myriad of mechanisms. The CorNeat KPro is engineered to be a permanent solution with robust integration into the eye’s tissues.
4. Following Boston KPro implantation, there is no access to the internal eye’s
compartments and thus surgical procedures cannot be carried out. The CorNeat KPro is engineered to ease anterior chamber access following implantation. The bays on the optic’s rim allow anterior chamber access following implantation and will stay accessible throughout the patient’s life. Posterior chamber access is readily available through the device’s integrating element, this should stay accessible throughout life as well.
Would a person with Stevens Johnson Syndrome be a candidate for the CorNeat KPro implantation?
See previous answer.