Donor Cornea Characterization System Phase II

DESCRIPTION (provided by applicant): Prior to surgery the donor cornea is screened for a number of pathologies and its history is examined for contra-indicated events, including the application of refractive surgery. Current techniques, such as topological measurement, produce significant errors, resulting in rejection of viable corneas and worse, potential use of modified corneas. With over a million corneal refractive procedures yearly, the potential of LASIK-modified corneas entering into the tissue bank system has increased significantly. The objective of this Phase II project is to further refine for commercialization the prototype device that was demonstrated in Phase I. Phase I data demonstrated a very high sensitivity and specificity for differentiating "normal", surgically unmodified, from LASIK-modified donor corneas. The Donor Cornea Characterization System (DCCS) has been shown to detect donor corneas which have been modified by refractive surgery, such as laser-assisted in-situ keratomleusis (LASIK). The DCCS employs a novel wavefront measurement system to optically characterize the corneas. This technology was integrated in Phase I into a laboratory device. The presence of scattering sources in the cornea produces scintillations that inhibit other wavefront sensors. Our device, which does not use traditional Shack-Hartmann technology, however, has the ability to make accurate wavefront measurements in the presence of scintillation. The 50 corneas, 20 of which had been LASIK modified, produced wavefront data that show clearly discernible differences in the nature of the wavefront distortions of unmodified (normal) corneas and those modified by LASIK. Phase II will produce a low-cost, table-top device for use in an eye bank environment. Our goal is to implement the device in the New Mexico Eye Bank for "real time" testing of donor corneas by the start of year 2. This "beta-testing" will collect data for several hundred corneas in addition to the continued data collection with the Phase I prototype device. Tissue Banks International is supporting the effort.