In Phase I Kestrel Corporation developed and demonstrated a retinal imaging system that combines multispectral imaging techniques with adaptive optics and image deconvolution to provide high resolution less than (<10 micrometers), in-vivo images. The enabling technologies such as the Shack-Hartmann wavefront sensor, adaptive optics, and image deconvolution algorithm have been demonstrated by Kestrel on human and non-human test objects. Others in the US and Spain have developed adaptive optics system for laboratory use and have achieved about 4 micrometer resolution images of the retina. These laboratory devices have given researchers a powerful tool for studying the smallest structures of the retina. Unfortunately, none of these systems are suitable for clinical use because of their small field of view (FOV) of 1 degree, than large size (greater than 30 square feet), and their complexity. Our system increases the FOV from 1 degree to 20 degrees and packages the technologies so that they easily fit on a standard fundus imager. We have demonstrated several patented technologies, including a dithered laser to overcome specular reflections and eliminate multiple Shack-Hartmann images for wavefront measurements. To reduce cost of the system and to reduce the complexity, a deconvolution algorithm has allowed us to use a simpler (17 element) bimorph adaptive optics mirror. Our prototype Phase I system with its patented modifications has solved the technical issues that have limited the use of adaptive optics to research instruments.
The first aim of Phase II is to design and develop a commercial prototype.
The second aim of this project is to evaluate, through a comprehensive human subjects study, not the research significance, but the clinical value of high resolution images of the retina and optic disc. The images will be evaluated by experienced ophthalmologists. The clinical functionality of the high resolution spectral fundus imager (HRSFI) will be evaluated by having the ophthalmologists compare images taken with a standard fundus camera and the HRSFI. A statistical evaluation of the double-blinded study will quantitate the value in diagnosing diseases such as pro-proliferative diabetic retinopathy, age-related macular degeneration, and glaucoma.
