A new device to improve screening of corneal transplant tissue

Period of Performance: 09/01/2014 - 08/31/2015

$132K

Phase 1 SBIR

Recipient Firm

Sarver and Associates, Inc.
Carbondale, IL 62902
Principal Investigator

Abstract

Marous, James R. An Eye Bank Endothelial Cell Counter Abstract Procurement of donor corneal tissue for transplant use is an important social service undertaken by largely underfunded eye banks. Tissue is not only harvested, but must be screened for a myriad of issues that may make the tissue unsuitable for transplant or pose a health risk to the tissue recipient. Donor tissue may be rejected for morphological issues including prior refractive surgeries (LASIK) or low endothelial cell count. Donor tissue that has undergone a procedure leaving an epithelial flap, such as LASIK, cannot be use for transplant as the flap will separate during suturing. Low endothelial cell count is also a basis for rejection of donor tissue as low endothelial cell count is a precursor to substantial corneal edema. Currently, eye banks screen donor tissue for these issues after the tissue has been harvested either as a whole globe or a corneal-scleral rim. Tissue is returned to the eye bank laboratory and a variety of tests are performed including slit lamp examinations to determine tissue efficacy and specular microscopy to determine endothelial cell count. In a prior funded project, VOL has developed a portable eye scanner device to screen tissue for prior refractive surgeries in the field, prior to tissue harvesting. This device not only generates a definitive metric for the determination of refractive surgery presence, but also reduces the cost associated with tissue harvesting should the tissue be deemed unusable. The current device only scans anterior corneal topography for refractive induced shape changes and tissue that passes this test still requires further examination for endothelial cell count before release for transplant. The current proposal therefore seeks to add the ability to determine endothelial cell count by modifying the existing device to produce a new device that will both scan anterior corneal topography for signs of refractive surgery and perform an endothelial cell count. Such a device will allow screening of both criteria before tissue harvesting thereby saving both significant cost and time.