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Completed

NCT Number: NCT01625598

Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnet Dulaney Perkins Eye Center, Mesa, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photography of the retina

Procedure

Every subject will undergo photography of the retina in both eyes

Retinal photography

Procedure

Device

Subjects will have photography of both eyes

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Digital Diagnostics, Inc.

Industry

Collaborators

  • Barnet Dulaney Perkins Eye Centers
  • 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

Registry information

Official study 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

Acronym: CDDR

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2012
Registry last updated
Apr 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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