Computer Detection of Diabetic Retinopathy Compared to Clinical Examination
CDDR
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
1 other identifier
observational
600
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 22, 2014
April 1, 2014
2 years
May 25, 2012
April 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity of detecting moderate non proliferative diabetic retinopathy or more severe DR and/or significant macular edema on a person-specific basis.
If the interval excludes differences of 10% or more (IDx worse than clinical examination), then the IDx system will be considered non-inferior to clinical examination by ophthalmologists. If IDx is non-inferior to clinical examination, a two-sided test of the null hypothesis that the difference in sensitivities is 0 will be conducted to determine if the IDX is superior to clinical examination. 24 McNemar's test for paired proportions will be used to test the difference in proportions.
Recruitment over 4 months
Secondary Outcomes (3)
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.
Four months
Sensitivity on an eye-specific basis [Clinical examination only]
Four months
Specificity on an eye-specific basis [Clinical examination only]
Four months
Study Arms (1)
People with diabetes
People with diabetes who are referred to an ophthalmologist for a dilated eye examination
Interventions
Every subject will undergo photography of the retina in both eyes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Digital Diagnostics, Inc.lead
- University of Pennsylvaniacollaborator
- University of Iowacollaborator
- The University of Texas Health Science Center, Houstoncollaborator
- Iowa Eye Center, Cedar Rapids IAcollaborator
- VitreoRetinal Surgery, PAcollaborator
- Retina Consultants Houstoncollaborator
- Barnet Dulaney Perkins Eye Centerscollaborator
Study Sites (7)
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206, United States
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016, United States
Iowa Eye Center
Cedar Rapids, Iowa, 52403, United States
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Robert Cizik Eye Clinic - University of Texas Houston
Houston, Texas, 77030, United States
Retina Consultants of Houston
Houston, Texas, 77090, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan Graff, MD
Barnet Dulaney Perkins Eye Center - Phoenix & Mesa AZ
- PRINCIPAL INVESTIGATOR
Brian Privett, MD
Iowa Eye Center, Cedar Rapids IA
- PRINCIPAL INVESTIGATOR
Timothy Johnson, MD
University of Iowa, Iowa City IA
- PRINCIPAL INVESTIGATOR
James Major, MD
Retina Consultants of Houston - Houston TX (2 locations)
- PRINCIPAL INVESTIGATOR
Judianne Kellaway, MD
Robert Cizik Eye Center - University of Texas Houston
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2012
First Posted
June 21, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 22, 2014
Record last verified: 2014-04