The fish scale based Biocornea: an off‐the shelf device for managing acute corneal perforations

Abstract

AbstractThe fish scale based ologen™ Biocornea is developed as an alternative to the temporary cadaveric corneas that do not meet all the criteria of transplantation grade tissue. Such temporary corneas (so‐called “0‐cornea”) can be used to patch a perforated, lacerated or ulcerated cornea for hours up to a few days, until a suitable donor cornea is procured for transplantation. The temporary cornea ensures integrity of the eye globe, maintaining inner eye structures and intraocular pressure so that other eye structures are not damaged while the patient waits for donor tissue. However, a 0‐cornea is not always available and for these circumstances the fish scale based Biocornea offers an alternative way to close the eye for a limited period of time to preserve the globe, until a human donor cornea is available. The Biocornea implant is composed of decellularized fish scales that have been acquired from a certified fish processing plant operating according to the EU Food Safety Management System. Initially, these ologen™ Biocorneas were tested for the intended purpose in a pig transplantation model. The favorable outcome of these experiments forms the basis for a “first in man” clinical trial which now runs in Cologne and Bochum in Germany as part of the ARREST BLINDNESS project. The experience obtained from the clinical trial will be the basis for further development of new prototype Biocorneas.