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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Barnet Dulaney Perkins Eye Center
    • Phoenix, Arizona, United States, 85016
      • Barnet Dulaney Perkins Eye Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Iowa Eye Center
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Department of Ophthalmology and Visual Sciences
  • Texas
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
    • Houston, Texas, United States, 77030
      • Robert Cizik Eye Clinic - University of Texas Houston
    • Houston, Texas, United States, 77090
      • Retina Consultants of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IDx LLC
• Collaborators: The University of Texas Health Science Center, Houston; University of Pennsylvania; University of Iowa; VitreoRetinal Surgery, PA; Iowa Eye Center, Cedar Rapids IA; 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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (ESTIMATE): June 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 22, 2014
• Last Update Submitted That Met QC Criteria: April 21, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: diabetic macular edema; proliferative diabetic retinopathy; Nonproliferative diabetic retinopathy; ophthalmologists; dilated eye exam
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 001 (NavyGHB)