Diabetic RetinopathyCDDRNCT01625598
Computer Detection of Diabetic Retinopathy Compared to Clinical Examination
An observational study of Diabetic Retinopathy, run by Digital Diagnostics, Inc. at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Photography of the retina and Retinal photography
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Iowa Eye Center
Cedar Rapids, Iowa, 52403
Retina Consultants of Houston
Houston, Texas, 77030
Robert Cizik Eye Clinic - University of Texas Houston
Houston, Texas, 77030
Retina Consultants of Houston
Houston, Texas, 77090
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Retinopathy
- Being tested
- Photography of the retina, Retinal photography
- Keywords
- Nonproliferative diabetic retinopathy, diabetic macular edema, proliferative diabetic retinopathy, ophthalmologists, dilated eye exam
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photography of the retinaProcedure or surgery
Every subject will undergo photography of the retina in both eyes
Retinal photographyProcedure or surgery
Device
Subjects will have photography of both eyes
| Study group | Role | What they receive |
|---|---|---|
| People with diabetes | People with diabetes who are referred to an ophthalmologist for a dilated eye examination Receives: Procedure: Photography of the retina; Procedure: Retinal photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Recruitment over 4 months
Secondary outcomes (3)
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]
Measured: 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.
Measured: 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.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Digital Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 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 Centers
- Responsible party
- Sponsor
- Investigators
- Jordan Graff, MD, Principal investigator, Barnet Dulaney Perkins Eye Center - Phoenix & Mesa AZBrian Privett, MD, Principal investigator, Iowa Eye Center, Cedar Rapids IATimothy Johnson, MD, Principal investigator, University of Iowa, Iowa City IAJames Major, MD, Principal investigator, Retina Consultants of Houston - Houston TX (2 locations)Judianne Kellaway, MD, Principal investigator, Robert Cizik Eye Center - University of Texas Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625598
- Sponsor's protocol ID
- 001
- Acronym
- CDDR
- Status last verified
- Apr 2014
- First submitted
- 25 May 2012
- Last updated
- 22 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01625598
- Acronym / sponsor ID
- CDDR / 001
- Conditions
- Diabetic Retinopathy
- Keywords
- Nonproliferative diabetic retinopathy, diabetic macular edema, proliferative diabetic retinopathy, ophthalmologists, dilated eye exam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Digital Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- 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 Centers
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with diabetes | – | Procedure: Photography of the retina, Procedure: Retinal photographyPeople with diabetes who are referred to an ophthalmologist for a dilated eye examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photography of the retinaEvery subject will undergo photography of the retina in both eyes | Procedure or surgery | People with diabetes |
| Retinal photographyDevice Subjects will have photography of both eyes | Procedure or surgery | People with diabetes |
Primary outcome
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.
3 secondary outcomes
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
Sensitivity on an eye-specific basis [Clinical examination only]
Time frame: Four months
Specificity on an eye-specific basis [Clinical examination only]
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Graff, MD principal investigator
Barnet Dulaney Perkins Eye Center - Phoenix & Mesa AZ
Brian Privett, MD principal investigator
Iowa Eye Center, Cedar Rapids IA
Timothy Johnson, MD principal investigator
University of Iowa, Iowa City IA
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Digital Diagnostics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2014.