SBIR Phase I: Development of a novel, highly efficient Descemet's Membrane Endothelial Keratoplasty preparation device expands the donor pool

The broader/commercial impact of this SBIR Phase I project will study and improve the process of corneal graft preparation in eye banks for use in vision-restoring transplant procedures to treat corneal diseases, affect more than over 4 million people in the United States. Descemets membrane endothelial keratoplasty (DMEK) is an advanced procedure involving transplantation of a thin layer of the cornea with outstanding clinical outcomes. However, this places a significant burden on eye banks as they use a difficult, time- and cost-intensive process to isolate the thin layer of the donor cornea (DMEK graft), subsequently provided to a surgeon for transplantation. The proposed research will enable development and evaluation of a novel to decrease the difficulty of DMEK graft preparation, reduce the time required, and expand the eligible donor pool. Improving the graft preparation process will result in increased economic efficiency within eye banks, and help enable greater access to vision-restoring DMEK procedures to individuals in the United States. This project seeks to develop and evaluate a novel, first-in-class graft preparation device that standardizes, de-skills, and improves the viability of the liquid bubble technique (LBT) for DMEK graft preparation. The proposed device overcomes the major barriers to LBT adoption: (1) consistent needle insertion into the correct tissue plane and (2) endothelial cell loss (ECL) due to high pressure in the cornea. It does so via a stabilizing corneal base in conjunction with a needle insertion system to allow for simple, standardized DMEK preparation in under 5 minutes with less than 5% failure rates at appropriate graft viability, even in diabetic and obese donor corneas. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.