SBIR-STTR Award

The long-term objective of this application is to develop an imaging device for the early detection, diagnosis and quantification of the degree of midperipheral retinal ischemia in Diabetic Retinopathy (DR). DR is one of the more debilitating potential outcomes of diabetes posing a major threat to the quality of life of diabetics. Experts believe that DR is the leading cause of blindness in the industrialized world in people between the ages of 25 and 74 years old. The American Academy of Ophthalmology states that DR is the leading cause of blindness among working Americans and currently affects nearly seven million people in the U.S. Early detection can help treat DR and salvage about 90 percent of vision loss, but about one-third of the diabetic population remains undiagnosed, translating into approximately 5.7 million people in the U.S. Delay in the primary diagnosis of diabetes allows diabetic complications to progress significantly before detection further increasing the risks associated with the disease by making the treatment much more complicated. Diabetes management guidelines advocate initiation of therapeutic intervention early in the prognosis of the disease. Estimates of diabetics in the U.S. with DR range from 15% to as high as 40%. The goal of Neuro Kinetics diabetic screening methodology is to detect the primary effects of DR or secondary phenomena that are the direct result of vascular damage, well before the patients develop proliferative DR or severe diabetic macular edema. To develop a prototype imaging device using a combination of analytical and experimental methods to validate the imaging device will include the following specific aims: (1) develop the prototype imaging hardware for early detection, diagnosis, and quantification of the degree of midperipheral retinal ischemia in DR - the most significant issue is the hardware design of the system; (2) develop prototype software that will modify Neuro Kinetics existing I-Portal(tm) software and supplement it with DR screening specific stimulus presentation and results analysis software; 3) perform proof-of-concept testing on a limited sample of normal and advanced DR patients; and 4) analyze data and prepare a Phase II SBIR plan to assess the sensitivity and specificity of the testing algorithm over a full range of severity of DR. Earlier diagnosis of DR could facilitate intervention at a stage that may prevent or lessen permanent damage from the ravages of the disease in turn, improving patient quality of life and reducing lifetime treatment costs. Experts believe that Diabetic Retinopathy is the leading cause of blindness in the industrialized world in people between the ages of 25 and 74 years old. There is wide spread agreement that our current eye care delivery system cannot meet the screening needs of these patients by relying on traditional clinical eye examinations by eye care professionals. Neuro Kinetics proposes to develop a rapid, noninvasive screening technology based on images of how the eye responds to unique patterns of light to increase the opportunity for earlier diagnosis.

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The long-term objective of this application is to develop an imaging device for the early detection, diagnosis and quantification of the degree of midperipheral retinal ischemia in Diabetic Retinopathy (DR). Earlier diagnosis of DR could facilitate intervention at a stage that may prevent or lessen permanent damage from the ravages of the disease, in turn, improving patient quality of life and reducing lifetime treatment costs. DR is one of the more debilitating potential outcomes of diabetes posing a major threat to the quality of life of diabetics. Experts believe that DR is the leading cause of blindness in the industrialized world in people between the ages of 25 and 74 years old. The American Academy of Ophthalmology states that DR is the leading cause of blindness among working Americans and currently affects nearly seven million people in the U.S. Early detection can help treat DR and salvage about 90 percent of vision loss, but about one-third of the diabetic population remains undiagnosed, translating into approximately 5.7 million people in the U.S. Delay in the primary diagnosis of diabetes allows diabetic complications to progress significantly before detection further increasing the risks associated with the disease by making the treatment much more complicated. Diabetes management guidelines advocate initiation of therapeutic intervention early in the prognosis of the disease. Estimates of diabetics in the U.S. with DR range from 15% to as high as 40%. The goal of Neuro Kinetics diabetic screening methodology is to use a noninvasive, objective measure of diabetes-related damage to the peripheral retina that contributes to the development of central vision loss and the growth of abnormal blood vessels that can bleed and scar, leading to blindness. Unlike existing screening methods which employ photography of the back of the eye and reading centers, this device can provide an instantaneous answer to the patient and/or their doctor of the severity of the disease and indicate if immediate specialty eye care is warranted. By comparing the responses of an individual's pupil to varying brightness of lights directed either to the center of vision or to the peripheral vision, we can detect progressive retinal damage from DR while controlling for the effects of cataracts, medications, and autonomic dysfunction. Our preliminary data from a Phase I study has established testing conditions that appear to be capable of distinguishing individuals with moderate or severe DR from normal individuals with less than a 1:1000 false positive rate for normal people. We have the following specific aims for Phase II: (1) to develop a clinical version of the testing device that is self-contained and can operate more easily and rapidly in a lighted area; (2) to develop control, recording and automatic analysis software for assessment of data quality and interpretation; (3) to perform clinical testing on a total of 200 normal and diabetic subjects to establish the discrimination capabilities of the instrument as a screening tool and (4) to develop an application for pre-commercial FDA approval and testing.

Public Health Relevance:
According to the American Academy of Ophthalmology, Diabetic Retinopathy is the leading cause of blindness among working Americans and currently affects nearly seven million people in the U.S. There is widespread agreement that the current U.S. eye care delivery system cannot meet the screening needs of these patients by relying on traditional, clinical eye examinations. Neuro Kinetics is developing a rapid, noninvasive screening technology based on images of the pupil's response to unique patterns of light to detect retinal damage from diabetes at a stage that would warrant intervention and therapy to protect sight.

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