KeraKlear Keratoprosthesis Orphan Device Study for Multiple Corneal Graft failures and Severe Limbal Stem Cell Deficiency in Aniridia IDE

DESCRIPTION provided by applicant The objective of this grant proposal is to perform a clinical study which will allow the first foldable and injectable artificial cornea the KeraKlear to be used in the United States market for treatment of corneal blindness This device may be implanted through an incision size that is approximately th the size of the incision that is required for the most popular artificial cornea available in the U S The smaller incision size is expected to allow a much quicker surgery for patients and a more accelerated recovery as compared to the currently available artificial corneas In addition the KeraKlear artificial cornea may be implanted in many patients with cornea blindness without penetration into the anterior chamber This avoids two of the most serious complications of artificial cornea implantation including internal infection of the eye endophthalmitis and severe bleeding expulsive hemorrhage The use of the KeraKlear artificial cornea also avoids the common complications of corneal transplantation including high astigmatism corneal graft failure and corneal graft rejection Finally the KeraKlear would enable the treatment of cornea blindness in a much larger number of patients Currently corneal transplantation is limited to about per year worldwide because of the lack of suitable donor corneas This represents only of the million people worldwide who have cornea blindness in both eyes By making the KeraKlear artificial cornea available a significantly larger percentage of the cornea blind patients around the world could be treated A new type of foldable and injectable artificial cornea has been developed for placement through a small incision mm In this project we will perform clinical studies to determine the safety and efficacy of this new device Successful completion of the study will lead to the availability of this less invasive artificial to cornea blind patients in the U S