AI-Assisted Detection of Posterior Segment Diseases: DR, AMD, RVO, and Glaucoma

March 10, 2026 updated by: Dong Geun Kim, Inje University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Busan, South Korea, 47392
        • Inje University Busan Paik Hospital
      • Busan, South Korea, 49267
        • Kosin University Gospel Hospital
      • Yangsan, South Korea, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-Assisted Reading
Readers interpret the fundus images with AI-generated outputs available.
Device: VUNO Med-Fundus AI
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).
No Intervention: Unassisted Reading
Readers interpret fundus images without access to the AI system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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) 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.
Through study completion, approximately 2 months
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) 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.
Through study completion, approximately 2 months
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.
Through study completion, approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

Pusan National University Hospital
Dong-A University Hospital
Pusan National University Yangsan Hospital
Kosin University Gospel Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-07-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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