SBIR-STTR Award

In order to reduce rates of preventable blindness, screening for treatable eye diseases has become increasingly important as the population ages in the United States and around the world. Early detection and diagnosis is vital to preserve retinal and optic nerve function. Currently, routine eye examinations are performed by highly skilled practitioners using complex and expensive ophthalmic devices. As a result, patients without access to skilled practitioners are at risk for visual loss. Additionally, capturing and storing images of the back of the eye is critical to good ophthalmic care in many cases. Traditional fundus cameras are expensive, large and also require a skilled technician to operate. While the recorded images are in general of high quality, current fundus cameras are not well adapted to screening and transport. In order to address the need for an accurate, user-friendly, durable, hand-held and portable camera system for screening, early diagnosis and follow up of retinal and optic nerve diseases, a new affordable imaging system is required. This Phase I SBIR application proposes to address these needs by conceptualizing the design of a hand- held pen-sized fundus camera. Such camera contains optical and electronic components within the same housing. The operator brings the front lens of the camera into contact with the patient's cornea. The focusing, image acquisition and analysis is performed automatically by the camera. The camera notifies the operator of successful image acquisition by an audio signal. The acquired image or images are either displayed on a small integrated screen or transmitted wirelessly to a nearby computer for a more though inspection and storage. The Phase I work is aimed at developing and constructing the imaging and illumination paths of the camera housed in the same hand-held structure. Other parts of the out-of-form prototype camera, such as illumination sources and electronics, will be located in a bench-top setting, and image analysis is performed by a PC. Using the constructed prototype, some preliminary fundus imaging will be performed in-vivo. The outcome of the project is a small bench top prototype platform with a hand- held unit that will serve as a launching pad for miniaturization efforts scheduled in Phase II. The conducted research will determine the practicality and ease of use of the camera, as well as determine the potential problems and solutions for obtaining good quality retinal images. At the conclusion of Phase I the feasibility of the hand-held retina camera will be demonstrated.

Public Health Relevance:
The proposed compact hand-held medical camera provides a dependable and simple way of conducting routine inspections of the human retina. Once properly positioned on a dilated eye, it automatically acquires high quality images of the retina and optic nerve that allow a medical professional to identify and follow common vision threatening disorders. In the majority of cases a trained user can obtain acceptable fundus images on patients in isolated, remote and underserved regions thereby reducing medical costs and rates of severe visual loss.

Thesaurus Terms:
Active Follow-Up; Address; Age; Ambulatory Care Nursing; Back; Blindness; Caring; Cell Communication And Signaling; Cell Signaling; Childhood; Chronic Care; Clinic Nursing; Clinical; Clinical Research; Clinical Study; Complex; Computer Programs; Computer Systems; Computer Software; Computerized Medical Record; Computers; Cornea; Cranial Nerve Ii; Cranial Nerve Ii Diseases; Cranial Nerve Ii Disorder; Data; Designing Computer Software; Devices; Diagnosis; Diagnostic; Disease; Disorder; Disorder Of The Optic Nerve; Dorsum; Early Diagnosis; Electronic Medical Record; Electronics; Ethics Committees, Research; Eye; Eye Exam; Eye Examination; Eye Diseases; Eye, Artificial; Eyeball; Fundus; Fundus Photography; General Practices; Hand; Housing; Human; Human, General; Irbs; Illumination; Image; Image Analyses; Image Analysis; Institutional Review Boards; Internal Medicine; Intervention; Intervention Strategies; Intracellular Communication And Signaling; Intraocular Pressure; Light; Lighting; Man (Taxonomy); Man, Modern; Measurement; Medical; Medical Record, Computerized; Miniaturisations; Miniaturization; Miniaturizations; Modeling; Neural-Optical Lesion; Nursing Homes; Ocular Prosthesis; Ocular Tension; Office Nursing; Ophthalmic Examination And Evaluation; Optic Nerve; Optic Nerve Diseases; Optic Neuropathy; Optics; Outcome; Output; Patients; Personal Computers; Phase; Photoradiation; Physicians; Physiologic Intraocular Pressure; Population; Position; Positioning Attribute; Power Sources; Power Supplies; Price; Prisons; Process; Roc Analysis; Research; Research Ethics Committees; Retina; Retinal; Risk; Sbir; Sbirs (R43/44); Sched; Schedule; Screening Procedure; Second Cranial Nerve; Second Cranial Nerve Diseases; Sight; Signal Transduction; Signal Transduction Systems; Signaling; Small Business Innovation Research; Small Business Innovation Research Grant; Software; Software Design; Solutions; Source; Structure; System; System, Loinc Axis 4; Technology; Telemetries; Telemetry; Testing; Training; United States; Vision; Visit; Work; Base; Biological Signal Transduction; Computer Program/Software; Corneal; Cost; Design; Design And Construction; Designing; Develop Software; Developing Computer Software; Disease/Disorder; Early Detection; Eye Disorder; Eye Fundus Photography; Eye Prosthesis; Follow-Up; Image Evaluation; Imaging; Imaging Modality; Improved; In Vivo; Instrument; Interventional Strategy; Laptop; Lens; Novel; Nursing Home; Ophthalmopathy; Optic Imaging; Optic Nerve Disorder; Optical Fiber; Optical Imaging; Pediatric; Pricing; Prototype; Public Health Relevance; Screening; Screenings; Second Cranial Nerve Disorder; Software Development; User-Friendly; Visual Prosthesis

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.

Public Health Relevance:
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.