Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Procedure: Photography of the retina
* Procedure: Retinal photography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People with diabetes<br>People with diabetes who are referred to an ophthalmologist for a dilated eye examination | Procedure: Photography of the retina<br>* Every subject will undergo photography of the retina in both eyes<br>Procedure: Retinal photography<br>* Device Subjects will have photography of both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: Specificity on a person-specific basis Sensitivity on an eye-specific basis [Clinical examination only] Specificity on an eye-specific basis [Clinical examination only] | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonproliferative diabetic retinopathy, diabetic macular edema, proliferative diabetic retinopathy, ophthalmologists, dilated eye exam