This SBIR application will revolutionize the methodology for routine examination of the back of the eye by developing an easy-to-use, pocket-sized, inexpensive digital camera for documenting retinal and optic nerve diseases. In order to reduce rates of preventable vision loss, the early diagnosis of treatable eye diseases has become increasingly important, especially as the global population ages. Early disease diagnosis is vital to preserving retinal and optic nerve function. The widely available direct ophthalmoscope is used routinely but only with difficulty. It has a small field of view, provides a fleeting image and leaves no examination record. Although ground-breaking when it was invented in the mid-19th century, this instrument is no longer a cutting edge tool in global effort to reduce vision loss. Traditional fundus cameras are a valuable technology, but they are expensive and bulky, and are typically used by trained technicians in well funded eye care centers. As a result, a lack of a quality retinal examination puts many people at risk for vision loss. Housed in a small ergonomic design, the new camera drastically simplifies fundus imaging. Quality photographs are obtained by bringing the smooth front tip of the camera into brief contact with a patient's anesthetized cornea. Image acquisition and analysis is performed automatically upon contact, and an audible signal informs the examiner the process is complete. The images are saved internally and can be wirelessly transmitted to a nearby computer for visualization and archival storage. Once the end user realizes the value of this product, concerns regarding corneal contact will dissipate, and this new camera will replace the direct ophthalmoscope with 21st century technology. This Phase II program is aimed at developing optical, mechanical, electronic and image analysis aspects of the camera, which must conform to a number of demanding performance and miniaturization specifications. The outcome of this project will be several clinically tested commercial prototypes, which can be exhibited to potential investors and customers, such as large ophthalmic companies or end users. It will serve as the basis in Phase III for high-volume manufacturing process development, registration studies, and launch.
The proposed ultra-portable hand-held wireless fundus camera provides an effective and simple approach to inspecting the human retina and documenting the findings. It replaces the direct ophthalmoscope as a more reliable and advanced medical device. The images can be collected during routine visits to primary care providers or specialists and in other high volume settings thereby reducing rates of vision loss and lowering health care costs, and improving the quality of life for millions of people.