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

April 21, 2014 updated by: IDx LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
Recruitment over 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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]
Four months
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.
Four months
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.
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IDx LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Marta Eliza Miller Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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