Diabetic RetinopathyNCT04805541
Detection and Classification of Diabetic Retinopathy From Posterior Pole Images With A Deep Learning Model
An observational study of Diabetic Retinopathy and Diabetic Eye Problems, run by Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi at 1 site in Turkey (Türkiye).
Trial summary
The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema
- What is being tested?
- Color Fundus Photography, Mydriatic Agent and EyeCheckup - AI Based DR Screening
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 4 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: * Primary care clinic - invitation to volunteer, * Diabetic Patients * Eighteen years of age or older * Have been referred to an ophthalmologist for eye examination to screen for diabetic retinopathy * Diseases Polyclinic with the diagnosis of diabetes and were able to view the posterior polar region of the eye with an ophthalmic camera. 900 volunteer patients who applied to the Akdeniz University Endocrinology and Metabolic
Who may be able to join
- A diagnosis of diabetes mellitus
- Understanding of study and provision of written informed consent
- 18 years of age or older
- 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
Who cannot join
- No diagnosis of diabetes mellitus
- Potential subject cannot understand study or informed consent
- A history of retinal vascular disease other than diabetic retinopathy that may affect the appearance of the retina or optic disc
- Previous intraocular surgery including cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy
- Pregnant women or women with gestational diabetes mellitus
- A media opacity in either eye that is severe enough to preclude good retinal photography
Show all 11Show fewer
- Permanent vision impairment in one or both eyes
- The participant is contraindicated for imaging with fundus imaging systems used in the study:
- Participant is hypersensitive to light
- Participant recently received photodynamic therapy (PDT)
- Participant uses drugs that cause photosensitivity
Trial locations and contacts
1 site in 1 country.
About this study
The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. The longer a person has diabetes, the more likely it is to develop diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people between the ages of 20 and 64. The most important complication of diabetes leading to vision loss is diabetic retinopathy. Depending on this, macular edema, bleeding into the retina and vitreous,neovascular glaucoma can cause blindness.
Diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). Diabetic retinopathy is a retinal disease that can often be stopped with early diagnosis, but if neglected, it can lead to severe vision loss, including permanent blindness. Diabetes has high morbidity and there are millions of people who should be screened for diabetic retinopathy (DR). Annual eye screening is recommended for all diabetic patients since vision loss can be prevented if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is less than that needed to screen a growing diabetic population. Therefore, the automatic DR screening system will be able to screen more diabetic patients and diagnose them early.
Read more
EyeCheckup is an automated retinal screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DR. This study is designed to assess the safety and efficacy of EyeCheckup.
The study is a single center study to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy. EyeCheckup is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).
Read the detailed description
This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR.
This study was carried out in a single center at Akdeniz University Faculty of Medicine with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting.
Methods and tools to be used in the study:
- Fundus photography with non-mydriatic camera and classification of diabetic retinopathy with artificial intelligence algorithm,
- Evaluation of seven field dilated fundus images by retina specialists and comparison of results for clinical validation of the system.
Clinical and laboratory tests to be performed:
- Fundus photography with a non-mydriatic camera. In this study, no invasive procedure is applied to the patient, the retinal photograph will be taken with a special digital camera called a fundus camera. In patients whose non-mydriatic image cannot be obtained, tropicamide drops will be instilled to dilate the pupil, and then photographs will be taken.
- Pupil dilation will be achieved by instilling Tropicamide drops in both eyes of the patient, and then 4 quadrant photographs of both eyes will be taken with a mydriatic fundus camera.
After exclusions, this study will enroll up to 900 subjects who are diagnosed with diabetes by the endocrinology polyclinic and meet the eligibility criteria. Participants who meet the eligibility criteria will be recruited after obtaining written informed consent from primary health care providers. Subjects will undergo fundus photography per, Food and Drug Administration (FDA) cleared, ophthalmic cameras (product code: HKI). Images will be taken according to a specific EyeCheckup imaging protocol provided to the ophthalmic camera operator and then analyzed by the EyeCheckup device.
The photography protocol consists of two images of the ocular fundus (one optic disc nerve centered, one macula centered), obtained from both eyes of enrolled participants.
After the retinal images taken from ophthalmic cameras (product code: HKI), images are analyzed with EyeCheckup and a scan report is prepared. If it is necessary to enlarge the pupils, eye enlarging eye drops are applied and wait 15-30 minutes. This information is noted. DR is diagnosed by examination by a retina specialist with the captured images. EyeCheckup success rate is calculated by comparing both reports.
- Being tested
- Color Fundus Photography, Mydriatic Agent, EyeCheckup - AI Based DR Screening
- 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 PhotographyProcedure or surgery
Subjects will undergo fundus photography before and after administration of mydriatic agent.
Mydriatic AgentDrug
Also called Tropicamide drops
Subjects will be administered mydriatic medication to dilate their pupils.
EyeCheckup - AI Based DR ScreeningDevice
Screening for existence of "More than mild" or "Vision-threatening" Diabetic Retinopathy, and/or Diabetic Macular Edema.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity(mtmDR)
Sensitivity for detecting more than mild diabetic retinopathy
Measured: 1 visit (1 day)
Sensitivity(vtDR)
Sensitivity for detecting vision threatening diabetic retinopathy
Measured: 1 visit (1 day)
Specificity(mtmDR)
Specificity for detecting more than mild diabetic retinopathy
Measured: 1 visit (1 day)
Specificity(vtDR)
Specificity for detecting vision threatening diabetic retinopathy
Measured: 1 visit (1 day)
Secondary outcomes (2)
Diagnosability
percentage of patients with image quality sufficient for EyeCheckup to produce an output to patients with image quality sufficient for the clinical reference standard to produce an output
Measured: 1 Day
Non-Dilated EyeCheckup Usage
Percentage of participants for whom Non-Dilated Images were sufficient to use EyeCheckup
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Feb 2022
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor
- Investigators
- A Burak Bilgin, Assoc. Prof., Principal investigator, Instructor, Retinal Surgeon, Academic Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805541
- Sponsor's protocol ID
- EC-2021DR-TR
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2021
- Last updated
- 15 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual data will be shared.
Publications
Aydemir M, Bilgin AB, Sari R, Dogan ME, Bulut M, Akar Y. Assessment of Correlation Between Diabetic Retinopathy and Metabolic Biomarkers Using Artificial Intelligence. J Diabetes Res. 2026 Jan 14;2026:9085827. doi: 10.1155/jdr/9085827. eCollection 2026.
PubMed 41541002Dogan ME, Bilgin AB, Sari R, Bulut M, Akar Y, Aydemir M. Head to head comparison of diagnostic performance of three non-mydriatic cameras for diabetic retinopathy screening with artificial intelligence. Eye (Lond). 2024 Jun;38(9):1694-1701. doi: 10.1038/s41433-024-03000-9. Epub 2024 Mar 11.
PubMed 38467864
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Classification of Diabetic Retinopathy From Posterior Pole Images With A Deep Learning Model
- ClinicalTrials.gov ID
- NCT04805541
- Acronym / sponsor ID
- EC-2021DR-TR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Ural Telekomunikasyon Sanayi Ticaret Anonim SirketiIndustry (pharma, biotech, devices)
- Collaborators
- Akdeniz University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Posted 15 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. The longer a person has diabetes, the more likely it is to develop diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people between the ages of 20 and 64. The most important complication of diabetes leading to vision loss is diabetic retinopathy. Depending on this, macular edema, bleeding into the retina and vitreous,neovascular glaucoma can cause blindness.
Diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). Diabetic retinopathy is a retinal disease that can often be stopped with early diagnosis, but if neglected, it can lead to severe vision loss, including permanent blindness. Diabetes has high morbidity and there are millions of people who should be screened for diabetic retinopathy (DR). Annual eye screening is recommended for all diabetic patients since vision loss can be prevented if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is less than that needed to screen a growing diabetic population. Therefore, the automatic DR screening system will be able to screen more diabetic patients and diagnose them early.
EyeCheckup is an automated retinal screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DR. This study is designed to assess the safety and efficacy of EyeCheckup.
The study is a single center study to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy. EyeCheckup is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).
Detailed description
This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR.
This study was carried out in a single center at Akdeniz University Faculty of Medicine with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting.
Methods and tools to be used in the study:
- Fundus photography with non-mydriatic camera and classification of diabetic retinopathy with artificial intelligence algorithm,
- Evaluation of seven field dilated fundus images by retina specialists and comparison of results for clinical validation of the system.
Clinical and laboratory tests to be performed:
- Fundus photography with a non-mydriatic camera. In this study, no invasive procedure is applied to the patient, the retinal photograph will be taken with a special digital camera called a fundus camera. In patients whose non-mydriatic image cannot be obtained, tropicamide drops will be instilled to dilate the pupil, and then photographs will be taken.
- Pupil dilation will be achieved by instilling Tropicamide drops in both eyes of the patient, and then 4 quadrant photographs of both eyes will be taken with a mydriatic fundus camera.
After exclusions, this study will enroll up to 900 subjects who are diagnosed with diabetes by the endocrinology polyclinic and meet the eligibility criteria. Participants who meet the eligibility criteria will be recruited after obtaining written informed consent from primary health care providers. Subjects will undergo fundus photography per, Food and Drug Administration (FDA) cleared, ophthalmic cameras (product code: HKI). Images will be taken according to a specific EyeCheckup imaging protocol provided to the ophthalmic camera operator and then analyzed by the EyeCheckup device.
The photography protocol consists of two images of the ocular fundus (one optic disc nerve centered, one macula centered), obtained from both eyes of enrolled participants.
After the retinal images taken from ophthalmic cameras (product code: HKI), images are analyzed with EyeCheckup and a scan report is prepared. If it is necessary to enlarge the pupils, eye enlarging eye drops are applied and wait 15-30 minutes. This information is noted. DR is diagnosed by examination by a retina specialist with the captured images. EyeCheckup success rate is calculated by comparing both reports.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Primary care clinic - invitation to volunteer, * Diabetic Patients * Eighteen years of age or older * Have been referred to an ophthalmologist for eye examination to screen for diabetic retinopathy * Diseases Polyclinic with the diagnosis of diabetes and were able to view the posterior polar region of the eye with an ophthalmic camera. 900 volunteer patients who applied to the Akdeniz University Endocrinology and Metabolic
Key inclusion criteria (5 listed)
- A diagnosis of diabetes mellitus
- Understanding of study and provision of written informed consent
- 18 years of age or older
- 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 (11 listed)
- No diagnosis of diabetes mellitus
- Potential subject cannot understand study or informed consent
- A history of retinal vascular disease other than diabetic retinopathy that may affect the appearance of the retina or optic disc
- Previous intraocular surgery including cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy
- Pregnant women or women with gestational diabetes mellitus
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 PhotographySubjects will undergo fundus photography before and after administration of mydriatic agent. | Procedure or surgery | – |
| Mydriatic AgentAlso: Tropicamide dropsSubjects will be administered mydriatic medication to dilate their pupils. | Drug | – |
| EyeCheckup - AI Based DR ScreeningScreening for existence of "More than mild" or "Vision-threatening" Diabetic Retinopathy, and/or Diabetic Macular Edema. | Device | – |
Primary outcome
Sensitivity(mtmDR)
Time frame: 1 visit (1 day)
Sensitivity for detecting more than mild diabetic retinopathy
Sensitivity(vtDR)
Time frame: 1 visit (1 day)
Sensitivity for detecting vision threatening diabetic retinopathy
Specificity(mtmDR)
Time frame: 1 visit (1 day)
Specificity for detecting more than mild diabetic retinopathy
Specificity(vtDR)
Time frame: 1 visit (1 day)
Specificity for detecting vision threatening diabetic retinopathy
2 secondary outcomes
Diagnosability
Time frame: 1 Day
Non-Dilated EyeCheckup Usage
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41541002Aydemir M, Bilgin AB, Sari R, Dogan ME, Bulut M, Akar Y. Assessment of Correlation Between Diabetic Retinopathy and Metabolic Biomarkers Using Artificial Intelligence. J Diabetes Res. 2026 Jan 14;2026:9085827. doi: 10.1155/jdr/9085827. eCollection 2026.
- Derived from this study: PubMed 38467864Dogan ME, Bilgin AB, Sari R, Bulut M, Akar Y, Aydemir M. Head to head comparison of diagnostic performance of three non-mydriatic cameras for diabetic retinopathy screening with artificial intelligence. Eye (Lond). 2024 Jun;38(9):1694-1701. doi: 10.1038/s41433-024-03000-9. Epub 2024 Mar 11.
- Individual participant dataSharing planned: No. No individual data will be shared.
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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.
A Burak Bilgin, Assoc. Prof. principal investigator
Instructor, Retinal Surgeon, Academic Advisor
1 site 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 and Diabetic Eye Problems, run by Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi at 1 site in Turkey (Türkiye).
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 5 inclusion and 11 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 15 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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(mtmDR) (time frame: 1 visit (1 day)). The study lists 4 primary outcomes in all. 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 NCT04805541, which also lists 2 linked publications.
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 15 Jul 2024.