Clinical trial NCT01625598: Computer Detection of Diabetic Retinopathy Compared to Clinical Examination
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: Nonproliferative diabetic retinopathy
diabetic macular edema
proliferative diabetic retinopathy
ophthalmologists
dilated eye exam
Lead sponsor: Digital Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
name: University of Iowa
name: The University of Texas Health Science Center, Houston
name: Iowa Eye Center, Cedar Rapids IA
name: VitreoRetinal Surgery, PA
name: Retina Consultants Houston
name: Barnet Dulaney Perkins Eye Centers
First posted: 2012-06-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with diabetes, eighteen years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.

Brief summary: 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.

Detailed description: The project is a multicenter, observational study to compare the accuracy of the IDX-DR computer detection system to board certified ophthalmologists performing dilated eye examination at identifying between no or mild NPDR without clinically significant diabetic macular edema from more than mild NPDR with or without CSDME. Approximately 400-600 persons with diabetes will be recruited through 5 clinical centers. The ophthalmologist who examines the patient will evaluate and record the status of the eye based on his/her clinical examination. The study subjects will then have two fundus photographs taken of each eye. The photographic images will be transferred to a central Reading Center at the University of Pennsylvania and interpreted by professional graders. The Reading Center will then transfer the images to IDx-DR, the computer detection system. IDx-LLC, the Sponsor of this study, will have no access to the images. Data from the Reading Center interpretation will be considered the "gold standard". The results of the clinical examination and IDX-DR will be compared against this gold standard as well as against each other.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of detecting moderate non proliferative diabetic retinopathy or more severe DR and/or significant macular edema on a person-specific basis.
timeFrame: Recruitment over 4 months
Secondary outcomes:
measure: Specificity (true negatives divided by true negatives plus false positives) at detecting more than moderate non proliferative diabetic retinopathy and/or significant macular edema on a person-specific basis.
timeFrame: Four months
measure: Sensitivity on an eye-specific basis [Clinical examination only]
timeFrame: Four months
measure: Specificity on an eye-specific basis [Clinical examination only]
timeFrame: Four months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Cedar Rapids
country: United States
facility: Iowa Eye Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Department of Ophthalmology and Visual Sciences
state: Iowa
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Houston
country: United States
facility: Robert Cizik Eye Clinic - University of Texas Houston
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Barnet Dulaney Perkins Eye Center - Phoenix & Mesa AZ
name: Jordan Graff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa Eye Center, Cedar Rapids IA
name: Brian Privett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa, Iowa City IA
name: Timothy Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Consultants of Houston - Houston TX (2 locations)
name: James Major, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Cizik Eye Center - University of Texas Houston
name: Judianne Kellaway, MD
role: PRINCIPAL_INVESTIGATOR
References: