INTRA-KER - Pilot Study Testing an Hybrid Intra-Corneal Prosthesis with Dehydrated Corneal Tissue Scaffold for the Treatment of Corneal Blindness

Abstract:

Corneal disease is the second most common cause of blindness, posing a significant public health burden. Although the cornea is themost commonly transplanted tissue, 53% of the global population have no access to donor corneas. While remarkable progress hasbeen achieved in the field, a sustainable solution is required to overcome global shortage of quality donor corneas, broadentransplant eligibility to include 'high risk' cases and address the finite lifespan of the donor graft due to immune rejection andprogressive endothelial cell loss. Currently available artificial prosthesis are trans-corneal, thereby creating a direct communicationto outside environment and invariably resulting in suboptimal visual rehabilitation and sight-threatening complications.While conventional wisdom has dictated that corneal clarity is dependent on endothelial function, we have recently observed thatthe pre-Descemet stroma can remain optically transparent even in the absence of corneal endothelium. Inspired by this breakthrough discovery, the project aims to test and develop a novel hybrid intracorneal prosthesis with an optical lens systempre-mounted onto a dehydrated corneal tissue scaffold consisting of thin pre-descemetic stroma. In the absence of endothelium, theprime alloimmune target of rejection, the acellular tissue scaffold obviates the risk of rejection while serves as a biologic barrier thatmaintains the nominal corneal structure.Iterative design, development, validation and verification shall be performed to establish the proof of concept and prepare a fullyfunctional device for certification and eventual market launch. INTRA-KER represents a major potential shift in the treatmentparadigm for eye disease, wherein functional endothelium may no longer be an absolute requirement for vision.