A Device for Preloaded, Trifolded Grafts to Facilitate Descemet Membrane Endothelial Keratoplasty

Abstract

Descemet membrane endothelial keratoplasty (DMEK) is the most efficacious partial endothelial keratoplasty, offering the highest likelihood of 20/20 vision and the shortest recovery times. However, current devices do not effectively address the difficult step of unrolling the corneal graft within the eye which is the greatest barrier to DMEK adoption. Here, we present the design, development, and testing of a novel device that simplifies and standardizes DMEK graft transplantation. The patent-pending cartridge facilitates the trifold technique, a graft preparation method that allows the graft to naturally unroll in the eye and reduces time-consuming manipulation steps required in alternative techniques. Injection molding was used to manufacture devices which were tested with research-grade corneal grafts. The cartridge's design allows it to fit into a typical corneoscleral incision, maintains trifolded grafts (p = 0.006), and reduces endothelial cell loss (ECL) (p = 0.049). These results demonstrate that the device introduced here is suitable for DMEK and may simplify this procedure for corneal surgeons.