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Home » Clinical Trials » Diabetic Retinopathy

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Photography of the retina and Retinal photography to evaluate Diabetic Retinopathy

Research Study Title

A Multicenter Masked Study to Compare Analysis of the Detection Program IDx-DR Against Standard of Care Clinical Examination by Ophthalmologists to Differentiate Levels of Diabetic Retinopathy and Diabetic Macular Edema

Purpose

The hypothesis is that computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Board-certified ophthalmologist.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

IDx LLC

Duration

5 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • a diagnosis of diabetes mellitus

  • subject understands study and has signed informed consent

  • no history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed);

  • other than cataract surgery, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease

  • no media opacity precluding good retinal photography

  • age 18 or older

Exclusion Criteria:

  • no diagnosis of diabetes mellitus

  • potential subject cannot understand study or informed consent

  • a history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc

  • previous intraocular surgery other than cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy

  • a media opacity in either eye that is severe enough to preclude good retinal photography

Site Locations (7)

Country State City Zip Facility and Contact
United States Arizona Mesa 85206 Barnet Dulaney Perkins Eye Center
Stephanie Pilcher
602-977-6110
spilcher@bdpec.com

Jordan Graff, MD
Principal Investigator
United States Arizona Phoenix 85016 Barnet Dulaney Perkins Eye Center
Patti Crincoli
602-508-4871
Pcrincoli@bdpec.com

Jordan M. Graff, MD
Principal Investigator
United States Iowa Cedar Rapids 52403 Iowa Eye Center
Elizabeth Rhodes
319-362-3937
erhodes@iowaeyecenter.com

Brian Privett, MD
Principal Investigator
United States Iowa Iowa City 52242 University of Iowa Department of Ophthalmology and Visual Sciences
Connie Hinz
319-467-5183
connie-fountain@uiowa.edu

Timothy Johnson, MD
Principal Investigator
United States Texas Houston 77090 Retina Consultants of Houston
Lela Johnstone
281-587-1987
lela.johnstone@houstonretina.com

James Major, MD
Principal Investigator
United States Texas Houston 77030 Retina Consultants of Houston
Shayla Friday
281-970-9660
shayla-friday@houstonretina.com

James Major, MD
Principal Investigator
United States Texas Houston 77030 Robert Cizik Eye Clinic - University of Texas Houston
Laura Baker
713-559-5263
laurabaker@cizikeye.org

Judianne Kellaway, MD
Principal Investigator

NCT ID: NCT01625598

Date Last Changed: August 20, 2012

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