DETECTION SYSTEM FOR REFRACTIVE SURGERY IN DONOR EYES

DESCRIPTION (provided by applicant): Vision Optimization is submitting a Phase I SBIR to develop and validate a simple, rapid, reliable, and sensitive software detection tool, based on corneal topography that will identify human donor eyes that have had previous laser refractive surgery. The technique must be noninvasive and must not require excessive manipulation of the globe. In addition, it must be amenable to acquisition "in the field," at the donor bedside, since approximately half of eyes in the U.S. are excised in situ as corneo-scleral rims, rather than whole globes. Corneal topography currently consists of many technologies and surface representations for shape analysis, including surface height-based systems, as well as slope-based curvature systems. Each technology has individual advantages and our software product will be adaptable to multiple technologies. Phase I of this submission will have 2 objectives. The first objective is to create a software product that takes conreal topographic maps as inputs and produces a prediction as to the presence of previous refractive surgeries. The second objective is to quantitatively very to operation of the software on a serious of topographic maps with theoretical representations of non-refractive surgery corneas, post-myopic refractive surgery eyes and post-hyperopic/keratoconic refractive surgery eyes. A future Phase II grant application will seek to further validate this software through additional studies consisting of a retrospective study on living refractive surgery patients and prospectively through a series of donor eyes collected as part of the grant. Further development in Phase III will seek preparation of the product for release and sale as well as exploring further markets such as military pilot flight screening.