NCT07318428Completed
AI-Assisted Detection of Posterior Segment Diseases: DR, AMD, RVO, and Glaucoma
A Multicenter Clinical Study to Validate the Performance Improvement of Fundus Photography Reading Software
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 23 Dec 2025
- Start date
- 20 Feb 2026
- Primary completion date
- 3 Apr 2026
- Lead sponsor
- Inje University
- Diseases
- Glaucoma, Macular degeneration, Diabetic eye disease
- NCT number
- NCT07318428
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 20 Feb 2026 to the primary completion date, 3 Apr 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.