Diabetic RetinopathyNCT05808699
Camera Qualification Study
An observational study of Diabetic Retinopathy, run by Digital Diagnostics, Inc. at 9 sites in United States.
Trial summary
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- handheld fundus camera
- Type of treatment
- Medical device
- How many people
- 626 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Mar 2023to 30 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic - sampling method: non-probability sequential, invitation to volunteer
Who may be able to join
- 22 years of age or older
- Documented diagnosis of diabetes mellitus, as per any of the following:
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
- Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
- Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Currently participating in an interventional eye study
- Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
- Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation)
- Pregnancy
- Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
- History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
Show all 12Show fewer
- Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
- Any condition that is contraindicated for the use of the study camera
- Contraindication for imaging by devices used in the study due to any of the following:
- Subject is hypersensitive to light
- Subject recently underwent photodynamic therapy (PDT)
- Subject is taking medication that causes photosensitivity
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Lillestol Research, LLC
Fargo, North Dakota, 58104
Allure Health
Friendswood, Texas, 77546
East Cost Institute for Research
Jacksonville, Florida, 32216
Logan Health
Kalispell, Montana, 59901
Ocean Wellness Center
Miami Gardens, Florida, 33169
Infinity Clinical Research
Norco, California, 92860
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
Dream Team
Pomona, California, 91767
Mt. Olympus Medical Research
Sugar Land, Texas, 77479
About this study
Official title: Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.
Read the detailed description
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
- Conditions
- Diabetic Retinopathy
- Being tested
- handheld fundus camera
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handheld fundus cameraDevice
Fundus camera
| Study group | Role | What they receive |
|---|---|---|
| Fundus camera image | Subjects imaged with a fundus camera Receives: Device: handheld fundus camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity Corrected for Enrichment
Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1
Measured: Day 1
Secondary outcomes (1)
Observed Sensitivity and Specificity, Level II
Estimation diagnosability, and observed sensitivity and specificity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start3 Mar 2023
- Primary completion30 Nov 2023
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Digital Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Michael Abramnoff, MD, PhD, Study chair, Digital Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808699
- Sponsor's protocol ID
- DXSDR006
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abramoff MD, Lavin PT, Jakubowski JR, Blodi BA, Keeys M, Joyce C, Folk JC. Mitigation of AI adoption bias through an improved autonomous AI system for diabetic retinal disease. NPJ Digit Med. 2024 Dec 19;7(1):369. doi: 10.1038/s41746-024-01389-x.
PubMed 39702673
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05808699
- Acronym / sponsor ID
- DXSDR006
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Digital Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 11 Apr 2023 (actual)
- 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.
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.
Detailed description
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fundus camera image | – | Device: handheld fundus cameraSubjects imaged with a fundus camera |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic - sampling method: non-probability sequential, invitation to volunteer
Key inclusion criteria (8 listed)
- 22 years of age or older
- Documented diagnosis of diabetes mellitus, as per any of the following:
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (12 listed)
- Currently participating in an interventional eye study
- Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
- Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation)
- Pregnancy
- Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
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 |
|---|---|---|
| handheld fundus cameraFundus camera | Device | Fundus camera image |
Primary outcome
Sensitivity and Specificity Corrected for Enrichment
Time frame: Day 1
Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1
1 secondary outcome
Observed Sensitivity and Specificity, Level II
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 39702673Abramoff MD, Lavin PT, Jakubowski JR, Blodi BA, Keeys M, Joyce C, Folk JC. Mitigation of AI adoption bias through an improved autonomous AI system for diabetic retinal disease. NPJ Digit Med. 2024 Dec 19;7(1):369. doi: 10.1038/s41746-024-01389-x.
- Individual participant dataSharing planned: No
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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.
Michael Abramnoff, MD, PhD study chair
Digital Diagnostics, Inc.
9 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 9 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
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 and Specificity Corrected for Enrichment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808699, which also lists 1 linked publication.
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 Oct 2024.