SBIR-STTR Award

This Phase I program will develop a hand-held, battery-operated, non- mydriatic digital ophthalmoscope/fundus camera for diagnosis and documentation of ocular injury and disease. Current fundus cameras are not compact and rugged enough for battlefield use. It is a great challenge to provide an effective diagnostic tool for eye injuries, which constitute approximately 10% of combat casualties. Proposed non- mydriatic fundus camera will be suitable for use under field conditions that will permit acquisition and storage of digital images and rapid assessment of basic visual function. Our approach is to use a novel, a proprietary laser chip as scanning laser illumination and detection, which also maintain confocality. A Liquid Crystal Display and image processor provides immediate image display, long-term storage and telemedicine capability. The output digital format imaging permits transmission of the fundus image to distant sites where access to specialized care is available. The ophthalmoscope may be used by primary care physicians for diagnosis and treatment of eye diseases, which could greatly reduce medical costs in the U.S. The phase I program is designed to prove the feasibility of our device successful accomplishments of phase I will establish a foundation for prototype development of Phase II.Proposed Commercial Application:The proposed hand-held, non-mydriatic, digital ophthalmoscope/fundus cameral will be an extremely useful tool for ophthalmologists in non- office settings (bedside), for pediatric ophthalmologists and neurophthalmologists, and for primary care physicians and emergency care providers. They will be able to diagnose and document ocular trauma and eye diseases in an outpatient setting.

Thesaurus Terms:
biomedical equipment development, confocal scanning microscopy, diagnosis design /evaluation, eye disorder diagnosis, eye fundus photography, ophthalmoscopy clinical biomedical equipment, digital imaging, image processing, laser, rapid diagnosis, telemedicineNATIONAL EYE INSTITUTE

In this Phase II we propose to develop a low cost, hand-held, non- mydriatic ophthalmoscope. Since there are no compact or rugged non- mydriatic ophthalmpscopes for field use, the diagnosis and treatment of eye injuries require trained specialists at remote locations from emergency rooms or primary care facilities. The resulting delays in diagnosis and treatment for soldiers and civilians cause increases in visual disability. Our innovative ophthalmoscope will provide the much needed timely diagnosis of eye diseases and trauma. This novel ophthalmoscope also has the capability to administer basic visual function tests. it incorporates an addressable laser/detector array chip, a digital image processor, and a liquid crystal display in one system. Unlike conventional ophthalmoscopes, our device has NO moving parts or bulky optics. it may be either integrated with a digital camera or connected to a laptop computer. Results from Phase I efforts have demonstrated the feasibility of using the laser/detector array and bilens for confocal imaging. The objective of Phase II is to demonstrate confocal imaging of retina with a 256x256 laser/detector array. We will deliver a functional prototype at the end of this Phase II. PROPOSED COMMERCIAL APPLICATION: Once fully developed, the proposed ophthalmoscope will allow providers at forward medical facilities to image fundus of injured soldiers and civilians, and send the images to specialists at distant sites. The providers on the scene will be able to receive diagnostic interpretations and treatment recommendations from experts without delay