An observational study in Diabetic Retinopathy, sponsored by Digital Diagnostics, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-22.
Sponsored by Digital Diagnostics, Inc. · Observational
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.
791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's enrollment of 600 is above the median of 150 across 268 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Digital Diagnostics, Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
People with diabetes who are referred to an ophthalmologist for a dilated eye examination
Procedure: Photography of the retina · Procedure: Retinal photography
Every subject will undergo photography of the retina in both eyes
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.
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.
Time frame: Recruitment over 4 months
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: * Specificity on a person-specific basis * Sensitivity on an eye-specific basis \[Clinical examination only\] * Specificity on an eye-specific basis \[Clinical examination only\]
Time frame: 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.
Time frame: 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.
Time frame: Four months
The record gives a start of Apr 2012, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Digital Diagnostics, Inc.