Computer Detection of Diabetic Retinopathy Compared to Clinical Examination (CDDR)
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ClinicalTrials.gov Identifier: NCT01625598 |
Recruitment Status
:
Completed
First Posted
: June 21, 2012
Last Update Posted
: April 22, 2014
|
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Condition or disease | Intervention/treatment |
---|---|
Diabetic Retinopathy | Procedure: Photography of the retina Procedure: Retinal photography |
Study Type : | Observational |
Actual Enrollment : | 600 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 Start Date : | April 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |
Group/Cohort | Intervention/treatment |
---|---|
People with diabetes
People with diabetes who are referred to an ophthalmologist for a dilated eye examination
|
Procedure: Photography of the retina
Every subject will undergo photography of the retina in both eyes
Procedure: Retinal photography
Device Subjects will have photography of both eyes |
- Sensitivity of detecting moderate non proliferative diabetic retinopathy or more severe DR and/or significant macular edema on a person-specific basis. [ Time Frame: Recruitment over 4 months ]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.
- 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. [ Time Frame: Four months ]
Secondary Outcome Variables:
- Specificity on a person-specific basis
- Sensitivity on an eye-specific basis [Clinical examination only]
- Specificity on an eye-specific basis [Clinical examination only]
- Sensitivity on an eye-specific basis [Clinical examination only] [ Time Frame: Four months ]Analysis of secondary outcomes will follow the same approach as for the primary outcome analysis of paired proportions as described above for the comparison of person-specific sensitivity.
- Specificity on an eye-specific basis [Clinical examination only] [ Time Frame: Four months ]Analysis of secondary outcomes will follow the same approach as for the primary outcome for analysis of paired proportions as described above for the comparison of person-specific sensitivity.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625598
United States, Arizona | |
Barnet Dulaney Perkins Eye Center | |
Mesa, Arizona, United States, 85206 | |
Barnet Dulaney Perkins Eye Center | |
Phoenix, Arizona, United States, 85016 | |
United States, Iowa | |
Iowa Eye Center | |
Cedar Rapids, Iowa, United States, 52403 | |
University of Iowa Department of Ophthalmology and Visual Sciences | |
Iowa City, Iowa, United States, 52242 | |
United States, Texas | |
Retina Consultants of Houston | |
Houston, Texas, United States, 77030 | |
Robert Cizik Eye Clinic - University of Texas Houston | |
Houston, Texas, United States, 77030 | |
Retina Consultants of Houston | |
Houston, Texas, United States, 77090 |
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 |
Responsible Party: | IDx LLC |
ClinicalTrials.gov Identifier: | NCT01625598 History of Changes |
Other Study ID Numbers: |
001 |
First Posted: | June 21, 2012 Key Record Dates |
Last Update Posted: | April 22, 2014 |
Last Verified: | April 2014 |
Keywords provided by IDx LLC:
Nonproliferative diabetic retinopathy diabetic macular edema proliferative diabetic retinopathy ophthalmologists dilated eye exam |
Additional relevant MeSH terms:
Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |