Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

Diabetic Retinopathy Clinical Trial

— CDDR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625598
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: April 21, 2014
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: IDx LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Procedure:
• Photography of the retina
Every subject will undergo photography of the retina in both eyes
• Retinal photography
Device Subjects will have photography of both eyes

Locations

Country	Name	City	State
United States	Iowa Eye Center	Cedar Rapids	Iowa
United States	Retina Consultants of Houston	Houston	Texas
United States	Retina Consultants of Houston	Houston	Texas
United States	Robert Cizik Eye Clinic - University of Texas Houston	Houston	Texas
United States	University of Iowa Department of Ophthalmology and Visual Sciences	Iowa City	Iowa
United States	Barnet Dulaney Perkins Eye Center	Mesa	Arizona
United States	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona

Sponsors (8)

Lead Sponsor	Collaborator
IDx LLC	Barnet Dulaney Perkins Eye Center, Iowa Eye Center, Cedar Rapids IA, Retina Consultants Houston, The University of Texas Health Science Center, Houston, University of Iowa, University of Pennsylvania, VitreoRetinal Surgery, PA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No