MedTrace Logo

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

NCT07318428 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-11

No results posted yet for this study

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 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

Interventions

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).

Sponsors & Collaborators

  • Dong-A University Hospital

    collaborator OTHER

  • Kosin University Gospel Hospital

    collaborator OTHER

  • Pusan National University Hospital

    collaborator OTHER

  • Pusan National University Yangsan Hospital

    collaborator OTHER

  • Inje University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2026-04-30
Completion
2026-05-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318428 on ClinicalTrials.gov