Diabetic RetinopathyAIMDRNCT06112691
ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)
An observational study of Diabetic Retinopathy, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.
Trial summary
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock
- Type of treatment
- Medical device
- How many people
- 660 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Feb 2022to Nov 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 660 participants were planed to include in study, 410 of them had diabetes mellitus and 250 participants were as a control group without diagnosis of diabetes mellitus. All participants were selected for the study based on the following inclusion and exclusion criteria
Who may be able to join
- Documented diagnosis of Diabetes mellitus as defined by:
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA) B. Hemoglobin A1c (HbA1c)>= 6.5% based on repeated assessments C. Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments D. Oral Glucose Tolerance test with 2 hr plasma glucose >= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
- Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose >=200mg/dL (11.1 mmol/L).
- Understanding of the Study and willingness and ability to sign informed consent
- Patient age 18 or above
- Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes
- -
Who cannot join
- Patients under 18 years of age;
- Failure to give informed consent;
- Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.
- A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061
About this study
Official title: USING ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
Read the detailed description
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
This study is planned as a follow-up. Participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. Images will be taken according to a specific RAssbyAI Check Eye's imaging protocol provided to camera operator, and then analyzed by the RAssbyAI Check Eye's. The photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).
- Conditions
- Diabetic Retinopathy
- Being tested
- taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock
- Keywords
- Diabetic Retinopathy, Fundus photo, Artificail Intelligence, Diabetes Melitus, Screening, CheckEye, Fundus image, nonmydriatic 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.
taking fundus photos using non-mydriatic fundus camera - FundusScope RodenstockDevice
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
| Study group | Role | What they receive |
|---|---|---|
| main group | diabetes mellitus Receives: Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock | |
| control group | without diagnosis of diabetes mellitus without retinal diseases Receives: Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy
The accuracy of detecting of DR
Measured: Baseline-Month 12
Secondary outcomes (2)
The percent of invalid images
The percent of invalid images for analysing by neural network
Measured: Baseline-Month 12
The percent of false positive detection of DR
The percent of false positive detection of DR in individuals without DR
Measured: Baseline-Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Feb 2022
- Primary completionOct 2024 (estimated)
- Study completionNov 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Komisarenko Institute of Endocrinology and Metobolism, CheckEye LLC
- Responsible party
- Principal investigator, Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy
- Investigators
- Andrii MD Korol, PhD, Principal investigator, The Filatov Institute of Eye Diseases and Tissue Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112691
- Sponsor's protocol ID
- 24.01.2022
- Acronym
- AIMDR
- Status last verified
- Jun 2023
- First submitted
- 29 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USING ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY
- ClinicalTrials.gov ID
- NCT06112691
- Acronym / sponsor ID
- AIMDR / 24.01.2022
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Fundus photo, Artificail Intelligence, Diabetes Melitus, Screening, CheckEye, Fundus image, nonmydriatic camera
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue TherapyUniversity, hospital or other
- Collaborators
- Komisarenko Institute of Endocrinology and Metobolism, CheckEye LLC
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 1 Nov 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.
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
Detailed description
The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
This study is planned as a follow-up. Participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. Images will be taken according to a specific RAssbyAI Check Eye's imaging protocol provided to camera operator, and then analyzed by the RAssbyAI Check Eye's. The photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| main group | – | Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstockdiabetes mellitus |
| control group | – | Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstockwithout diagnosis of diabetes mellitus without retinal diseases |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 660 participants were planed to include in study, 410 of them had diabetes mellitus and 250 participants were as a control group without diagnosis of diabetes mellitus. All participants were selected for the study based on the following inclusion and exclusion criteria
Key inclusion criteria (7 listed)
- Documented diagnosis of Diabetes mellitus as defined by:
- Understanding of the Study and willingness and ability to sign informed consent
- Patient age 18 or above
- Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes
- -
Key exclusion criteria (4 listed)
- Patients under 18 years of age;
- Failure to give informed consent;
- Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.
- A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
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 |
|---|---|---|
| taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstockusing artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography. | Device | control group, main group |
Primary outcome
The accuracy
Time frame: Baseline-Month 12
The accuracy of detecting of DR
2 secondary outcomes
The percent of invalid images
Time frame: Baseline-Month 12
The percent of false positive detection of DR
Time frame: Baseline-Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- 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.
Andrii MD Korol, PhD principal investigator
The Filatov Institute of Eye Diseases and Tissue Therapy
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, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.
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 7 inclusion and 4 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 1 Nov 2023. 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 Ukraine. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrii MD Korol, PhD (380936327266, andrii.r.korol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy (time frame: Baseline-Month 12). 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 1 Nov 2023.