Computer Detection of Diabetic Retinopathy Compared to Clinical Examination (CDDR)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Diabetic Retinopathy	Procedure: Photography of the retina; Procedure: Retinal photography

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 Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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]
2. 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.
3. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Population

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.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

IDx LLC

University of Pennsylvania

University of Iowa

The University of Texas Health Science Center, Houston

Iowa Eye Center, Cedar Rapids IA

VitreoRetinal Surgery, PA

Retina Consultants Houston

Barnet Dulaney Perkins Eye Center

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	IDx LLC
ClinicalTrials.gov Identifier:	NCT01625598 History of Changes
Other Study ID Numbers:	001
First Posted:	June 21, 2012
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