SBIR-STTR Award

The objective of this research is to create a clinical prototype of a new optical coherence tomography (OCT) system for use in point of care settings. The target system price will be one third the price of currently available research OCT system while providing system performance comparable to other entry level OCT imaging systems. By breaking the $10,000 system barrier we will provide an incisive tool that will be disruptive to the market by making OCT accessible to most clinics. We have spoken with ophthalmologists who confirm the need for this system in the detection and monitoring of diabetic retinopathy, glaucoma, retinopathy of prematurity, and macular degeneration. Ophthalmology is the first clinical target but we have talked to users from other specialties including, ENT, oncology, dermatology, neurology, and gastroenterology. By significantly reducing instrument cost, this OCT system will be affordable for use at the point of care and in a wide range of research applications. This price point also opens markets in developing countries where the value of clinical OCT is understood, but currently clinical systems are too expensive. The research plan, proposed here, will create a prototype of the low cost instrument that utilizes an innovative system architecture based on newly available components while delivering all the imaging capabilities of OCT. We propose to achieve the following milestones: (1) Implement sub-systems as portable components, (2) Integrate sub-systems and software, and (3) Validate and test the complete portable system using an OCT eye phantom.

Public Health Relevance Statement:


Public Health Relevance:
The objective of this research is to create a clinical prototype of a new low cost optical coherence tomography (OCT) system. The proposed instrument will use novel system design and new components to reduce the user price by at least a factor of 3 compared to available OCT imaging systems. This will provide access to clinics and labs that previously could not afford OCT systems. Point of care use of OCT systems may quickly become standard with the availability of this system.

Project Terms:
Android; Antirrhinum; Architecture; arm; base; Caring; Clinic; Clinical; clinical application; Collimator; Computer software; Computer Systems; conditioning; Cornea; cost; Custom; Dermatology; design; Detection; Developing Countries; Devices; Diabetic Retinopathy; Diagnostic; Environment; Eye; eye center; fovea centralis; Gastroenterology; Glaucoma; Goals; Humidity; Image; imaging system; innovation; instrument; laptop; lens; Liquid substance; Macular degeneration; Marketing; Mechanics; medical specialties; Monitor; Neurology; novel; oncology; Ophthalmologist; Ophthalmology; Optical Coherence Tomography; Optics; Output; Patients; Performance; Phase; Physicians; point of care; Point-of-Care Systems; Price; Process; prototype; Provider; public health relevance; Pupil; Reading; Research; Retina; Retinal; Retinopathy of Prematurity; Risk; Sampling; Scanning; Shock; signal processing; Signal Transduction; Small Business Innovation Research Grant; software systems; solid state; Speed; Structure; System; system architecture; Tablets; Temperature; Testing; tissue phantom; tool; vibration; Writing

The objective of this research is to create a clinical prototype of a new optical coherence tomography (OCT) system suitable for diagnostic retinal imaging at the point of care. The target system price will be one third the price of currently available research OCT systems while providing performance comparable to other entry level OCT imaging systems. By breaking the $15,000 system barrier we will provide an incisive tool that will be disruptive to the market by making OCT accessible to clinics and health care professionals who previously could not afford this technology. We have spoken with ophthalmologists and optometrists who confirm the need for a low-cost portable system in the detection and monitoring of diabetic retinopathy, glaucoma, retinopathy of prematurity, and macular degeneration. Increased access to OCT can have a profound effect in ophthalmology. By significantly reducing instrument cost, this OCT system will be affordable for retinal screening at the point of care and in a wide range of research applications. This price point also opens markets in developing countries where the value of clinical OCT is understood, but currently clinical systems are too expensive. The research plan, proposed here, will create a prototype of the low cost OCT instrument suitable for clinical ophthalmic use. We propose to achieve the following milestones: (1) Improve design of low cost OCT. We will transition from off-the-shelf to custom parts to reduce system cost and improve performance over the Phase I prototype including increasing the A-scan rate to 80,000 lines per second. (2) Integrate OCT with handheld fundus camera. Our market research shows that this capability is important for clinical acceptability. (3) Develop new software for instrument control and image analysis. We will transition our software from Windows to Linux-based to increase performance. New image analysis packages will be developed with aid of a collaborator. (4) Test system on human subjects. Clinical performance will be assessed in a small clinical feasibility trial with our collaborator, Dr. Ulrich at the UNC Kittner eye center.

Public Health Relevance Statement:
The objective of this research is to create a clinical prototype of a new low cost optical coherence tomography (OCT) system. The proposed instrument will use a novel design to reduce the system price by at least a factor of 3 compared to available OCT imaging systems. This will provide access to clinics and labs that previously could not afford OCT systems. Point of care use of OCT systems may quickly become standard with the availability of this system.

NIH Spending Category:
Bioengineering; Biomedical Imaging; Clinical Research; Diabetes; Eye Disease and Disorders of Vision; Macular Degeneration; Neurodegenerative; Neurosciences

Project Terms:
Academy; Address; Adult; American; Area; Background Diabetic Retinopathy; base; Blindness; care providers; Caring; Cellular Phone; Clinic; Clinical; clinically relevant; Collaborations; Communities; Computer software; cost; Custom; design; Detection; Developing Countries; Development; Devices; Diabetes Mellitus; diabetic; diabetic patient; Diabetic Retinopathy; Diagnosis; Diagnostic; Disease; disease diagnosis; disorder of macula of retina; Equipment; Eye; eye center; Eye diseases; Feasibility Studies; feasibility trial; Fundus; fundus imaging; Fundus photography; Glaucoma; Goals; Hand; Health Professional; human subject; Image; Image Analysis; Imaging Device; imaging system; Impairment; improved; in vivo; Industry; instrument; Linux; machine vision; Macular degeneration; macular edema; Manufacturer Name; Market Research; Monitor; novel; Ophthalmologist; Ophthalmology; Ophthalmoscopes; Optical Coherence Tomography; Optometrist; Patients; Performance; Periodicity; Phase; point of care; Populations at Risk; portability; Price; Primary Health Care; prototype; Recommendation; Research; Resolution; Resources; Retina; Retinal; Retinal Diseases; retinal imaging; Retinopathy of Prematurity; Scanning; screening; Side; standard of care; Structure; Symptoms; System; Technology; Testing; tool; Translating; Vision; Visual Acuity; Work