The Corneat Everpatch - A Non-Degradable, Synthetic Tissue Alternative, For Ophthalmic Surgery. Pre-Clinical And Preliminary Clinical Data.

The purpose of these studies is to determine the safety profile of the CorNeat Everpatch, a synthetic and non-degradable alternative for tissue used in ophthalmic surgery. The CorNeat Everpatch was implanted contra-lateral to a reference and assessed throughout the follow up and histologically at termination in an animal model. Initial clinical assessment was performed in a small patient cohort and followed up clinically for at least 6 months. We present the local histopathological reaction and the short term clinical follow up data following implantation of the CorNeat EverPatch. 

Envigo CRO, Pre-clinical CRO specifying in ophthalmic surgery and its research.

Da Vinci Eye Clinic, Tibilisi, Georgia (Europe)

12 rabbits were implanted with the test device contralateral to the reference device. Patches were implanted under the conjunctiva and sutured to the sclera. Animals were evaluated clinically by a veterinary ophthalmologist throughout the trial regularly. Ten and 2 animals were euthanized at 3 and 6-months, respectively. At termination, the eyes were enucleated, examined microscopically, fixed, and subjected to histopathological processing & evaluation.

12 patients with glaucoma, following surgical intervention failure, were implanted with a Bearvaldt shunt that was concealed using the CorNeat Everpatch. The patches were not altered before implantation. Patients were followed up for a minimum of 6 months.

Histological findings in the CorNeat EverPatch implanted eyes displayed an expected, minor foreign body reaction and some mononuclear cell infiltration noted at the periphery of the patch while fibroblasts were seen within the patch. A more significant inflammatory reaction was observed in eyes implanted with the reference device composed of a mixed mononuclear cell infiltration made predominantly of lymphocytes. In both groups, no incidental lesion was observed.

Ocular findings in human subjects were limited to expected, minimal conjunctival congestion and swelling observed within the 1^st month after surgery. Two early onset exposures occurred. Both cases occurred immediately post op due to suture dehiscence and were corrected surgically.  

The CorNeat EverPatch is a synthetic, non-degradable alternative, to tissue, and appears to have acceptable local tolerability 3- and 6-months post implantation in a rabbit model when compared to a prevalently used, tissue derived, product. Furthermore, histopathological evaluation demonstrated progressive integration of the implant within the surrounding tissue.

Initial human data assents the safety of the device but longer follow up and a larger patient group is necessary to better understand how this material  performs long term and to better define the patient selection.