providing early detection of a leading cause of blindness
Diabetic retinopathy is the leading cause of preventable blindness among Americans aged 20-74 years old. In the past decade, photography-based retinal evaluations have shown to be effective in managing diabetic retinopathy and other eye diseases. But access to traditional tabletop retinal cameras is limited by their high costs, bulky nature, and need for skilled operators.
University of Michigan Kellogg Eye Center team Tyson Kim, M.D., Ph.D.; Maria Woodward, M.D., M.S.; and Yannis Paulus, M.D., are refining and clinically validating the RetinaScope, a compact, handheld device that produces wide-angle retinal images similar to those obtained with tabletop retinal cameras, but is portable, less expensive, and very easy to operate. Their work is part of a multi-institutional collaboration that includes University of California Berkeley (Dan Fletcher, Ph.D.) and Washington University in St. Louis (Todd Margolis, M.D., Ph.D.).
Diabetic retinopathy (DR) results when damaged and abnormal blood vessels in the light-sensitive tissue at the back of the eye begin to “leak.” It is the leading cause of vision loss in working- aged adults and accounts for 12 percent of all new cases of blindness in the United States every year. This project aims to prevent vision loss in treatable diseases like DR by providing high-quality imaging and increased accessibility.
Significant Need
DR can be safely and effectively monitored by photography, but traditional retinal cameras are expensive, bulky, and require specially trained operators. And despite widely accepted guidelines, nearly half of adults in the United States do not receive recommended examinations for DR. With RetinaScope, screening can be done by primary care physicians.
Compelling Science
This integrated approach utilizes a compact-sized, high-resolution camera with large data storage capacity and wireless data transfer capabilities of current mobile devices to capture retinal images for real-time or remote evaluation.
Competitive Advantage
The portability of the smartphone retinal camera simplifies and lowers the overhead costs associated with traditional retinal photography for primary care clinics, while providing high-quality imaging.
Overall Commercialization
- Intellectual Property: One patent pending and one provisional patent filed.
- Commercialization Strategy: Potential start-up company. Option to license to existing ophthalmologic company.
- Regulatory Pathway: 10(k) exemption pathway based on predicated devices, or 510(k) approval pathway predicated upon digital hand-held ophthalmoscopes.
- Product Launch Strategy: RetinaScope.
Milestones
- Design and test optical configurations to maximize field-of-view when imaging through a small aperture
- Design and test illumination configuration that reduces glare and optimizes images
- Determine imaging parameters for capturing multiple neighboring images to construct wide-angle view of retina
- Implement multi-image acquisition parameters utilizing on-device fixation display
- Demonstrate successful wide- field retina montage with images acquired through small pupil
- Initiate pilot clinical trial in validating smartphone images in detection of diabetic retinopathy
- Initiate collaborations for testing device in clinical settings outside the ophthalmology office
