Diabetic RetinopathyNCT05471986
Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi.
Trial summary
This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Dec 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic Patients of 22 years or older
Who may be able to join
- A diagnosis of either diabetes type 1 or diabetes type 2
- 22 years of age or older
- Patients Fundus images must include at least 1 macula centered and 1 optic disc nerve centered image
- All the subjects must be sequentially photographed meaning no omissions of data between a certain time frame by the sites providing images to ensure consecutive selection
- No history of any other retinal vascular disease, glaucoma, or another disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)
- Subject with image taken by color fundus photography that meets the following requirements:
Show all 9Show fewer
- The resolution of image is 1024×1024 pixels or higher
- The ability to provide a 7 standard or 4 wide field of view
- Must obtained from either Topcon NW400 or Cannon Model CR-2 AF or CR-2 Plus AF or Optomed Aurora Cameras along with the following data: their age, ethnicity and gender, patient ocular history as evaluated of verified by the clinical sites where data is obtained
Who cannot join
- No diagnosis of either diabetes type 1 or diabetes type 2
- The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the certified ophthalmologist who is grading the images.
Trial locations and contacts
No sites are listed yet.
About this study
This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.
Read the detailed description
This is a clinical diagnostic performance study for EyeCheckup with data obtained consecutively at multiple geographically different sites within the US population. These sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with EyeCheckup. Moreover, primary endpoints are devised that will be used to validate EyeCheckup to diagnose DR in the primary care and eye care settings. During this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to ETDRS on DRSS scale. The human grading output will be compared with diagnosis generated for diabetic retinopathy by AI software. A comparison of both these grades will be used to determine sensitivity and specificity for the EyeCheckup software for screening for diabetic retinopathy.
- Conditions
- Diabetic Retinopathy
- Being tested
- Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
- Keywords
- Diabetic Retinopathy, Artificial Intelligence, Deep Learning, Retinal images, Diabetic Macular Edema, Diabetic Eye Problems
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Fundus Photography/Non-Mydriatic Opthalmic CamerasDevice
Subjects will have underwent Fundus Photography using FDA approved non-mydriatic fundus cameras compatible with EyeCheckup which are either TOPCON NW400, CANNON CR2, CANNON CR2 Plus or OPTOMED AURORA IQ
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of EyeCheckup to detect more than mild diabetic retinopathy
Measured: 1 visit (1 day)
Sensitivity and Specificity of EyeCheckup to detect vision-threatening diabetic retinopathy
Measured: 1 visit (1 day)
Secondary outcomes (2)
Positive Predictive Value
Measured: 1 visit (1 day)
Negative Predictive Value
Measured: 1 visit (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rim Khazhin, Study chair, Ural Telekom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471986
- Sponsor's protocol ID
- EC-2023DR
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05471986
- Acronym / sponsor ID
- EC-2023DR
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Artificial Intelligence, Deep Learning, Retinal images, Diabetic Macular Edema, Diabetic Eye Problems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ural Telekomunikasyon Sanayi Ticaret Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Jul 2022 (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.
This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.
Detailed description
This is a clinical diagnostic performance study for EyeCheckup with data obtained consecutively at multiple geographically different sites within the US population. These sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with EyeCheckup. Moreover, primary endpoints are devised that will be used to validate EyeCheckup to diagnose DR in the primary care and eye care settings. During this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to ETDRS on DRSS scale. The human grading output will be compared with diagnosis generated for diabetic retinopathy by AI software. A comparison of both these grades will be used to determine sensitivity and specificity for the EyeCheckup software for screening for diabetic retinopathy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic Patients of 22 years or older
Key inclusion criteria (9 listed)
- A diagnosis of either diabetes type 1 or diabetes type 2
- 22 years of age or older
- Patients Fundus images must include at least 1 macula centered and 1 optic disc nerve centered image
- All the subjects must be sequentially photographed meaning no omissions of data between a certain time frame by the sites providing images to ensure consecutive selection
- No history of any other retinal vascular disease, glaucoma, or another disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)
Key exclusion criteria (2 listed)
- No diagnosis of either diabetes type 1 or diabetes type 2
- The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the certified ophthalmologist who is grading the images.
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 |
|---|---|---|
| Color Fundus Photography/Non-Mydriatic Opthalmic CamerasSubjects will have underwent Fundus Photography using FDA approved non-mydriatic fundus cameras compatible with EyeCheckup which are either TOPCON NW400, CANNON CR2, CANNON CR2 Plus or OPTOMED AURORA IQ | Device | – |
Primary outcome
Sensitivity and Specificity of EyeCheckup to detect more than mild diabetic retinopathy
Time frame: 1 visit (1 day)
Sensitivity and Specificity of EyeCheckup to detect vision-threatening diabetic retinopathy
Time frame: 1 visit (1 day)
2 secondary outcomes
Positive Predictive Value
Time frame: 1 visit (1 day)
Negative Predictive Value
Time frame: 1 visit (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. No individual data will be shared.
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
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.
Rim Khazhin study chair
Ural Telekom
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rim Khazhin (+905357666383, trials@eye-checkup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of EyeCheckup to detect more than mild diabetic retinopathy (time frame: 1 visit (1 day)). The study lists 2 primary outcomes in all. 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 29 Nov 2023.