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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| University of Iowa | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Iowa Eye Center, Cedar Rapids IA |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with diabetes | People with diabetes who are referred to an ophthalmologist for a dilated eye examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photography of the retina | Procedure | Every subject will undergo photography of the retina in both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Secondary Outcome Variables:
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Mesa | Arizona | 85206 | United States | ||
| Barnet Dulaney Perkins Eye Center |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| UNKNOWN |
| VitreoRetinal Surgery, PA | OTHER |
| Retina Consultants Houston | OTHER |
| Barnet Dulaney Perkins Eye Centers | NETWORK |
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| Retinal photography | Procedure | Device Subjects will have photography of both eyes |
|
| Four months |
| Sensitivity on an eye-specific basis [Clinical examination only] | 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. | Four months |
| Specificity on an eye-specific basis [Clinical examination only] | 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. | Four months |
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |