Development of The Multi-Electrode Electroretinogram: Technology, Application and Commercialization

Several prevalent, potentially blinding eye diseases begin with localized dysfunction of the retina which is difficult to sense using standard clinical measures; this is a significant challenge to early detection. Distribution of activity across the retina affects the distribution of potentials across the cornea. Therefore, functional deficits of the retina lead to alterations in the spatial distribution of electroretinogram (ERG) potentials on the cornea. No existing method to measure the spatial distribution of retinal health currently exploits this finding. The work described here is motivated by this gap in knowledge, and the potential clinical impact of a system which uses electrophysiological functional imaging of the retina for early detection and diagnosis of progressive eye disease. This thesis describes the design, prototyping, testing, and efforts to commercialization a novel technology for recording the spatial distribution of corneal potentials. This measurement technique is referred to as multi-electrode electroretinography (meERG). Central to the meERG system is a Contact Lens Electrode Array (CLEAr Assembly™), which samples corneal potentials at 33 locations simultaneously. The CLEAr Assembly™ has been prototyped and tested. Other major developments include a highly-detailed finite-element bioelectric model of a human eye used to solve the inverse problem (i.e. predict distribution of retinal activity from the recorded corneal potentials) implemented using SolidWorks and ANSYS Workbench 12.1. Methods to optimize the model and solve the inverse problem have been demonstrated.