Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Procedure: Photography of the retina; Procedure: Retinal photography

• Registration Number: NCT01625598
• Lead Sponsor: Digital Diagnostics, Inc.

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-25
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-21
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-21
• Last Update Posted: 2014-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with diabetes	Retinal photography	People with diabetes who are referred to an ophthalmologist for a dilated eye examination
People with diabetes	Photography of the retina	People with diabetes who are referred to an ophthalmologist for a dilated eye examination

Primary Outcome Measures

Name	Time	Method
Sensitivity of detecting moderate non proliferative diabetic retinopathy or more severe DR and/or significant macular edema on a person-specific basis.	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.

Secondary Outcome Measures

Name	Time	Method
Specificity on an eye-specific basis [Clinical examination only]	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.
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	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]	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.

Trial Locations

Locations (5)

Barnet Dulaney Perkins Eye Center; 🇺🇸 Phoenix, Arizona, United States

Iowa Eye Center; 🇺🇸 Cedar Rapids, Iowa, United States

University of Iowa Department of Ophthalmology and Visual Sciences; 🇺🇸 Iowa City, Iowa, United States

Robert Cizik Eye Clinic - University of Texas Houston; 🇺🇸 Houston, Texas, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States