SBIR-STTR Award

Since its first use in the retina in 1961, fluorescein angiography (FA) has been the gold standard for objective characterization of retinovascular disease (e.g. diabetic retinopathy, retinal vein occlusions, and choroidal neovascularization associated with age-related macular degeneration (AMD)). Despite its widespread use, FA is costly, invasive, and time consuming, limiting the usefulness as a screening tool. Optical coherence tomography (OCT) and its faster variation called spectral domain OCT (SDOCT) are interferometric imaging techniques which allow three-dimensional imaging of the retinal structure. This technique has enabled clinical imaging of retinal morphology and pathologic alteration with resolution nearly comparable to histologic sections. Because OCT is not capable of rendering most retinovascular abnormalities, it is frequently performed with FA to diagnose and manage patients with macular disease. As a potential alternative to FA in diagnosing retinovascular disease, we have developed an imaging method called phase contrast optical coherence tomography (PC-OCT) which uses specialized software analysis of data acquired from clinically available SDOCT imaging systems to provide the additional functionality of high resolution imaging of retinal vessels and choroidal neovascularization. To develop PC-OCT imaging as a non-invasive alternative for fluorescein angiography, we have the following goals: (1) improve the speed, accuracy and automation of PC-OCT imaging to allow for general clinical usage, and apply this developed technique towards disease targets of (2) retinal capillary non- perfusion in diabetic retinopathy and (3) choroidal neovascularization (CNV) in age-related macular degeneration (AMD). The visualization capabilities of PC-OCT imaging will be compared directly against fluorescein angiography images for subjects of the target diseases. Successful completion of the Phase I aims will lead to further development of PC-OCT imaging techniques and analysis for detection of vascular leakage and screening for sub-clinical CNV in asymptomatic fellow eyes. Developing motion contrast capabilities of PC-OCT to be used with clinically available SDOCT systems can establish a new non-invasive screening tool for retinovascular diagnosis. Earlier detection through non-invasive screening of AMD patients may enable earlier detection of subclinical CNV and initiation of therapy before central vision is lost. , ,

Public Health Relevance:
This proposal describes a new software product that enhances the diagnostic capability of optical coherence tomography (OCT), the most commonly performed retinal diagnostic test used in the US for evaluation of macular degeneration and diabetic retinopathy. By non-invasively providing high resolution retinovascular imaging, the product, phase contrast OCT (PC-OCT), may potentially replace fluorescein angiography, the current invasive and costly gold standard for retinovascular imaging. The proposed research plan improves the capabilities of PC-OCT and then does a head-to-head comparison with fluorescein angiography in evaluation of patients with wet macular degeneration and diabetic retinopathy.

Thesaurus Terms:
3,4-Didehydroretinal;3-D Imaging;3-Dehydroretinal;3d Imaging;Abscission;Age Related Macular Degeneration;Algorithms;Analysis, Data;Area;Artifacts;Au Element;Automation;Blindness;Blood;Blood Vessels;Blood Capillaries;Capillaries;Capillary;Capillary, Unspecified;Central Vein;Choroidal Neovascularization;Clinical;Coloring Agents;Computer Programs;Computer Software;Data;Data Analyses;Data Set;Dataset;Detection;Development;Diabetic Retinopathy;Diagnosis;Diagnostic;Diagnostic Method;Diagnostic Procedure;Diagnostic Technique;Diagnostic Tests;Disease;Disorder;Doppler Oct;Dyes;Early Diagnosis;Evaluation;Excision;Extirpation;Extravasation;Eye;Eyeball;Fluorescein;Fluorescein Angiography;Fluoresceins;Fluorescence Agents;Fluorescent Agents;Fluorescent Dyes;Fundus Photography;Goals;Gold;Head;Histologic;Histologically;Image;Image Analyses;Image Analysis;Imagery;Imaging Procedures;Imaging Techniques;Imaging, Three-Dimensional;Lead;Leakage;Lesion;Macular Degeneration;Macular Degenerative Disease;Maculopathy, Age-Related;Maps;Marketing;Medical Imaging, Three Dimensional;Methods;Methods And Techniques;Methods, Other;Morphologic Artifacts;Morphology;Motion;Neovascularization, Choroid;Newly Diagnosed;Noise;Oct Tomography;Ophthalmologist;Optical Coherence Tomography;Pathologic;Patients;Pb Element;Perfusion;Phase;Protocol;Protocols Documentation;Roc Analysis;Removal;Research;Resolution;Reticuloendothelial System, Blood;Retina;Retinal;Retinal Blood Vessels;Retinal Vein Occlusion;Retinal Vessels;Risk;Scanning;Screening Procedure;Secondary To;Sight;Software;Speed;Speed (Motion);Spillage;Stream;Structure;Structure Of Blood Vessel Of Retina;Surgical Removal;System;System, Loinc Axis 4;Technics, Imaging;Techniques;Three-Dimensional Imaging;Time;Tomography, Optical Coherence;Variant;Variation;Vision;Visualization;Work;Base;Capillary;Capillary Bed;Computer Program/Software;Data Acquisition;Dehydroretinal;Design;Designing;Disease/Disorder;Disorder Of Macula Of Retina;Early Detection;Eye Fundus Photography;Fluorescent Dye/Probe;Heavy Metal Pb;Heavy Metal Lead;Image Evaluation;Imaging;Imaging Modality;Improved;Instrument;Intravenous Injection;Processing Speed;Public Health Relevance;Resection;Retina Blood Vessel Structure;Retinal(2);Screening;Screenings;Senile Macular Disease;Tool;Vascular;Vein Occlusion

Since its introduction in the 1960's, fluorescein angiography (FA) has been the gold standard for retinal vascular diagnosis. However, FA is costly, invasive, and time-consuming, which limits its usefulness as a screening tool. As a potential non-invasive alternative to FA for diagnosing retinovascular disease, we have developed an imaging method called phase contrast optical coherence tomography (PC-OCT). Our technology uses specialized software analysis of data acquired from clinically available optical coherence tomography imaging systems to provide an additional functionality of three-dimensional angiography. The majority of eye care in the US is currently performed by optometrists, and in many underserved communities, they are the sole providers. Unfortunately, most optometrists cannot perform FA due to its requirement for intravenous injection. Therefore, retinal vascular diagnostics are limited to clinical exam and fundus photography. Patients receiving optometric care would benefit from a non-invasive alternative to FA for improved screening of retinovascular diseases, especially in these underserved communities. PC-OCT has the potential to provide a low-cost and convenient vascular screening method, which could result in timely referrals to retinal specialists, as well as improved visual outcomes. To advance PC-OCT as a retinovascular imaging tool, we have the following goals: (1) develop PC-OCT software into a faster automated platform for application to commercial spectral domain (SD-OCT) systems; (2) optimize optical scanner performance for imaging both dilated and non-dilated pupils; and (3) demonstrate the feasibility of PC-OCT as a wide-field screening diagnostic for diabetic retinopathy. The visualization capabilities of PC-OCT imaging will be compared directly against fundus photography, the current diagnostic standard for eye care professionals. Successful completion of Phase II will result in an automated software package capable of producing PC-OCT microvascular images from the raw data of a commercial SD-OCT system, allowing for convenient vascular imaging accessible to all eye care practitioners. This could lead to better-quality detection capabilities for retinovascular disease and potentially improved visual outcomes.

Public Health Relevance Statement:


Public Health Relevance:
This proposal describes a new software product that enhances the diagnostic capability of optical coherence tomography (OCT), the most commonly performed retinal diagnostic test used in the US for evaluation of macular degeneration and diabetic retinopathy. By non- invasively providing high resolution retinovascular imaging, the product, phase contrast OCT (PC-OCT), may potentially replace fluorescein angiography, the current invasive and costly gold standard for retinovascular imaging. The proposed research plan improves the capabilities of PC-OCT and then does a head-to-head comparison with fluorescein angiography in evaluation of patients with wet macular degeneration and diabetic retinopathy.

Project Terms:
Age; Algorithms; American; Angiography; Blindness; Blood capillaries; Blood Circulation; Blood Vessels; capillary; Caring; Choroidal Neovascularization; Classification; Clinical; commercial application; Communities; Computer software; Consult; cost; Data; Data Analyses; design; Detection; Development; Diabetic Retinopathy; Diagnosis; Diagnostic; Diagnostic tests; Disease; Dyes; Early Diagnosis; Evaluation; Eye; Financial compensation; Fluorescein Angiography; Fundus photography; Goals; Gold; head-to-head comparison; high risk; Image; Image Analysis; Imagery; Imaging Device; imaging modality; Imaging technology; improved; Informatics; instrument; intravenous injection; Lead; Legal patent; Macular degeneration; Methods; Microaneurysm; Motion; Mydriasis; neovascularization; Ophthalmologist; Optical Coherence Tomography; Optics; Optometrist; Outcome; Patients; Performance; Phase; Process; Provider; public health relevance; Pupil; Reading; Research; Research Infrastructure; Resolution; Retinal; Retinal Neovascularization; screening; Secondary to; software development; Solutions; Specialist; Speed (motion); System; Techniques; Technology; Time; tool; Vascular Diseases; Visual; visual feedback; Work