Cost-Effective OCT Detection of Vision-Threatening Macular Edema

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DESCRIPTION (provided by applicant): I The overall goal of the proposed SBIR program is to implement and evaluate a low cost, portable retinal camera, the Digital Light Ophthalmoscope (DLO), with retinal thickness measurement functionality provided by optical coherence tomography (OCT). The combined DLO-OCT system will cost-effectively identify patients with vision-threatening macular edema for referral and treatment. Vision loss due to untreated macular edema has reached epidemic levels and is the result of a wide variety of conditions, including diabetes and other retinal vascular diseases, inflammatory diseases, retinal traction, and complications of cataract surgery. To fully address this issue, screening tools from the community clinic to the ophthalmic exam lane must include quantitative retinal thickness measurements to seamlessly lead patients to vision-saving treatment. In response to the ever-growing costs and disparities in eye care, Aeon Imaging has proposed a novel retinal imaging device, the DLO. Unique to retinal cameras, Aeon's DLO uses a digital light projector for illumination and CMOS rolling shutter detection to provide high contrast, confocal views of the retina. Operators can image the retina at real-time frame rates using either red or green illumination without pupillary dilation. The DLO is microprocessor controlled, optically aligned through software, internet ready, and is compact and lightweight, making it easily detachable from a standard slit-lamp style alignment base for ease of transport. The target price point is well below competing products that use expensive scanning elements and laser illumination sources, and require time-consuming optical alignment. Aeon's DLO has been built and field tested at both Indiana University and at the Eastmont Wellness Center community clinic in Alameda County, CA. This community clinic provides county-insured eye care to underserved, mainly minority patients. During testing, diabetic macular edema (DME) was clearly indicated using OCT, but could be missed on the monoscopic fundus camera images commonly used for screening. DME is treatable if diagnosed in a timely manner, and therefore Aeon proposes to integrate novel cost- effective OCT technology, using a digital light projector and CMOS rolling shutter sensor, into the DLO to perform macular thickness measurements. In Phase I, Aeon proposes to develop and test the retinal thickness measurement accuracy of its DLO- OCT device, using Heidelberg Spectralis SLO/OCT measurements as the gold standard. If the DLO's new retinal thickness measurement technology is successful, the proposed DLO-OCT device will provide the means to accurately detect sight-threatening macular edema in patients requiring urgent referrals at a fraction of the cost. By reducing the cost of OCT technology, it wil be more widely used in both screening and ophthalmic care settings, helping to more accurately detect early signs of treatable vision loss.