Diabetic RetinopathyNCT07318428
AI-Assisted Detection of Posterior Segment Diseases: DR, AMD, RVO, and Glaucoma
A study testing VUNO Med-Fundus AI in people with Diabetic Retinopathy and Age Related Macular Degeneration, run by Inje University at 5 sites in South Korea.
Trial summary
The purpose of this multi-center study is to evaluate the extent to which AI-assisted fundus image interpretation improves the diagnostic performance of ophthalmologists. Rather than assessing the standalone algorithm performance, this study aims to determine the clinical value of using AI as a decision-support tool… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy, Age Related Macular Degeneration, Retinal Vein Occlusion
- What is being tested?
- VUNO Med-Fundus AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 20 Feb 2026to 22 May 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Ten readers will be recruited from five participating hospital sites, consisting of:
- Five ophthalmologists within three years of board certification
- Five ophthalmology residents
Ophthalmologists and residents of any age, sex, race, or ethnicity may participate as study readers. All readers must meet the following inclusion criteria:
- Licensed physicians qualified to interpret fundus images.
- Ophthalmologists within three years of board certification, or ophthalmology residents with no restriction on clinical experience.
- Able and willing to complete both the unassisted and AI-assisted reading sessions.
- Able to provide informed consent for participation in the reader study.
- Affiliated with one of the participating clinical sites.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: A Multicenter Clinical Study to Validate the Performance Improvement of Fundus Photography Reading Software
The purpose of this multi-center study is to evaluate the extent to which AI-assisted fundus image interpretation improves the diagnostic performance of ophthalmologists. Rather than assessing the standalone algorithm performance, this study aims to determine the clinical value of using AI as a decision-support tool within actual clinical workflows.
At each participating institution, five ophthalmologists within three years of board certification and five ophthalmology residents will participate as readers. All readers will interpret fundus images both with and without the AI-based assistance software. The study will quantitatively compare diagnostic accuracy and reading time across the two conditions for four posterior segment diseases: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma.
- Conditions
- Diabetic Retinopathy, Age Related Macular Degeneration, Retinal Vein Occlusion, Glaucoma, Glaucoma Suspect
- Being tested
- VUNO Med-Fundus AI
- Medical subject headings
- Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VUNO Med-Fundus AIDevice
The intervention consists of an AI-based fundus image interpretation software that provides automated outputs for 12 retinal and optic nerve findings (e.g., hemorrhage, exudates, drusen, optic disc change). The system does not generate a direct disease diagnosis. Instead, the AI displays the presence or absence of 12 predefined findings along with their lesion locations. Readers may use this finding-level information as decision-support when determining the presence of the four target diseases (diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma).
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Reading | Experimental | Readers interpret the fundus images with AI-generated outputs available. Receives: Device: VUNO Med-Fundus AI |
| Unassisted Reading | No intervention | Readers interpret fundus images without access to the AI system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of readers with and without AI assistance: Sensitivity
Sensitivity of reader diagnoses for each of the four target diseases (DR, AMD, RVO, glaucoma) and for any fundus abnormality will be assessed with and without AI assistance, using the image-level reference standard as the comparator, through two reading sessions in which all 10 readers review all cases-randomised for each reader-with a washout period implemented to mitigate recall bias.
Measured: Through study completion, approximately 2 months
Performance of readers with and without AI assistance: Specificity
Specificity of reader diagnoses for each of the four target diseases (DR, AMD, RVO, glaucoma) and for any fundus abnormality will be assessed with and without AI assistance, using the image-level reference standard as the comparator, through two reading sessions in which all 10 readers review all cases-randomised for each reader-with a washout period implemented to mitigate recall bias.
Measured: Through study completion, approximately 2 months
Reading time per image
Reading time per image will be measured during both unassisted and AI-assisted interpretation sessions. For each case, the total time from the moment the image is displayed to the moment the reader submits the final disease classification will be recorded automatically by the reading platform. Mean reading time per image will be calculated for each reader and compared between the two conditions to evaluate whether AI assistance reduces interpretation time.
Measured: Through study completion, approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start20 Feb 2026
- Primary completion3 Apr 2026
- Study completion22 May 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A University Hospital, Kosin University Gospel Hospital, Pusan National University Hospital, Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, Dong Geun Kim, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318428
- Sponsor's protocol ID
- 2025-07-033
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 23 Jun 2026
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study to Validate the Performance Improvement of Fundus Photography Reading Software
- ClinicalTrials.gov ID
- NCT07318428
- Acronym / sponsor ID
- 2025-07-033
- Conditions
- Diabetic Retinopathy, Age Related Macular Degeneration, Retinal Vein Occlusion, Glaucoma, Glaucoma Suspect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Dong-A University Hospital, Kosin University Gospel Hospital, Pusan National University Hospital, Pusan National University Yangsan Hospital
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 6 Jan 2026 (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 multi-center study is to evaluate the extent to which AI-assisted fundus image interpretation improves the diagnostic performance of ophthalmologists. Rather than assessing the standalone algorithm performance, this study aims to determine the clinical value of using AI as a decision-support tool within actual clinical workflows.
At each participating institution, five ophthalmologists within three years of board certification and five ophthalmology residents will participate as readers. All readers will interpret fundus images both with and without the AI-based assistance software. The study will quantitatively compare diagnostic accuracy and reading time across the two conditions for four posterior segment diseases: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Reading | Experimental | Device: VUNO Med-Fundus AIReaders interpret the fundus images with AI-generated outputs available. |
| Unassisted Reading | No intervention | –Readers interpret fundus images without access to the AI system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| VUNO Med-Fundus AIThe intervention consists of an AI-based fundus image interpretation software that provides automated outputs for 12 retinal and optic nerve findings (e.g., hemorrhage, exudates, drusen, optic disc change). The system does not generate a direct disease diagnosis. Instead, the AI displays the presence or absence of 12 predefined findings along with their lesion locations. Readers may use this finding-level information as decision-support when determining the presence of the four target diseases (diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma). | Device | AI-Assisted Reading |
Primary outcome
Performance of readers with and without AI assistance: Sensitivity
Time frame: Through study completion, approximately 2 months
Sensitivity of reader diagnoses for each of the four target diseases (DR, AMD, RVO, glaucoma) and for any fundus abnormality will be assessed with and without AI assistance, using the image-level reference standard as the comparator, through two reading sessions in which all 10 readers review all cases-randomised for each reader-with a washout period implemented to mitigate recall bias.
Performance of readers with and without AI assistance: Specificity
Time frame: Through study completion, approximately 2 months
Specificity of reader diagnoses for each of the four target diseases (DR, AMD, RVO, glaucoma) and for any fundus abnormality will be assessed with and without AI assistance, using the image-level reference standard as the comparator, through two reading sessions in which all 10 readers review all cases-randomised for each reader-with a washout period implemented to mitigate recall bias.
Reading time per image
Time frame: Through study completion, approximately 2 months
Reading time per image will be measured during both unassisted and AI-assisted interpretation sessions. For each case, the total time from the moment the image is displayed to the moment the reader submits the final disease classification will be recorded automatically by the reading platform. Mean reading time per image will be calculated for each reader and compared between the two conditions to evaluate whether AI assistance reduces interpretation time.
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 23 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VUNO Med-Fundus AI in people with Diabetic Retinopathy and Age Related Macular Degeneration, run by Inje University at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Performance of readers with and without AI assistance: Sensitivity (time frame: Through study completion, approximately 2 months). The study lists 3 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 23 Jun 2026.