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Computer Based Screening for Diabetic Retinopathy

Award Number: R44EY018280
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2007
PERIOD OF PERFORMANCE END DATE: 06/30/2015

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Computer Based Screening for Diabetic Retinopathy - DESCRIPTION (provided by applicant): The objective of this Phase II competitive renewal project is to implement a clinical study to collect data to validate EyeStar(tm), a software system as the basis for comprehensive telescreening for all stages of diabetic retinopathy (DR). According to the CDC, approximately 80 million people in the U.S. have some form of eye disease, including 20 million diabetics at risk for retinopathy. It is estimated that less than hal of those individuals with diabetes are screened periodically for DR. Lack of medical coverage and access to healthcare providers imposes major obstacles for nearly 10 million diabetics. Creating an affordable and accessible solution to providing screening services to these diabetics presents a significant challenge to the healthcare community. The objective of the original Phase II grant was to demonstrate a "top-down" screening algorithm for triaging normal, i.e. no disease, from suspect retinas using a new technique, amplitude modulation-frequency modulation (AM-FM), to analyze multi-field digital retinal images. As a result of the Phase II grant, the EyeStar(tm) software for diabetic retinopathy screening was developed. In this project, we will perform a clinical validation that will allow us to apply for 510(k) clearance by the Food and Drug Administration (FDA). To meet this goal, we have divided this proposal in three aims. In Aim #1, we will establish a clinical network and meet the requirements for the number of cases needed to perform a clinical study in order to obtain FDA clearance for our integrated, automatic screening system. In Aim #2, we will perform an independent validation for purposes of submitting to the FDA a 510(k) clearance application. In Aim #3, we will operate all the EyeStar(tm) components in a near "real-time" environment. This project is significant for two main reasons: increase of productivity and safety testing. Firs, by increasing the productivity of DR screening centers through automation, a much larger population of at-risk individuals will have access to this service, leading to improved productivit and quality of life through early detection and treatment. Second, by providing to the FDA a system that is highly effective and sensitive, we will insure that the safety requirements of semi-automatic screening for diabetic retinopathy are met. The FDA-cleared software will be integrated into our existing network of retinal screening sites in Texas and New Mexico as the first step toward commercialization.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2014 ( Subtotal = $623,330 )
2014	2014	VISIONQUEST BIOMEDICAL LLC	2501 YALE BOULEVARD SOUTHEAST	ALBUQUERQUE	NM	87106	BERNALILLO	USA	Vision Research	000	5	6/4/2014	SUPPLEMENT FOR EXPANSION	$623,330
														Subtotal = $623,330

Issue Date FY: 2013 ( Subtotal = $542,269 )
2013	2013	VISIONQUEST BIOMEDICAL LLC	2501 YALE BOULEVARD SOUTHEAST	ALBUQUERQUE	NM	87106	BERNALILLO	USA	Vision Research	000	5	8/28/2013	NON-COMPETING CONTINUATION	$542,269
														Subtotal = $542,269

Issue Date FY: 2012 ( Subtotal = $748,129 )
2012	2012	VISIONQUEST BIOMEDICAL LLC	2501 YALE BOULEVARD SOUTHEAST	ALBUQUERQUE	NM	87106	BERNALILLO	USA	Vision Research	000	4	7/1/2012	COMPETING CONTINUATION	$748,129
														Subtotal = $748,129

Issue Date FY: 2010 ( Subtotal = $388,526 )
2010	2010	VISIONQUEST BIOMEDICAL	7718 QUINTANA NORTHEAST	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Vision Research	000	3	2/5/2010	NON-COMPETING CONTINUATION	$388,526
														Subtotal = $388,526

Issue Date FY: 2009 ( Subtotal = $439,411 )
2009	2009	VISIONQUEST BIOMEDICAL	7718 QUINTANA NORTHEAST	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Trans-NIH Recovery Act Research Support	001	2	7/10/2009	SUPPLEMENT FOR EXPANSION	$58,717
2009	2009	VISIONQUEST BIOMEDICAL	7718 QUINTANA NORTHEAST	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Vision Research	000	2	1/16/2009	NON-COMPETING CONTINUATION	$380,694
														Subtotal = $439,411

Issue Date FY: 2008 ( Subtotal = $105,510 )
2008	2008	VISIONQUEST BIOMEDICAL	7718 QUINTANA NORTHEAST	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Vision Research	000	1	2/1/2008	NEW	$105,510
														Subtotal = $105,510

Grand Total All Awards = $2,847,175

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Computer Based Screening for Diabetic Retinopathy

Award Number: R44EY018280

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/01/2007

PERIOD OF PERFORMANCE END DATE: 06/30/2015

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