AI vs. Physician for Anti-VEGF Decision-Making: An RCT
NCT07328776 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-05-22
Summary
We developed an artificial intelligence system, called QiLin, which was designed to assist anti-VEGF treatment decisions in retinal diseases. QiLin was trained and validated via over 20,000 optical coherence tomography images from multicenter datasets, demonstrating strong performance on both internal and external validation. To evaluate its real-world clinical utility, we conducted a randomized controlled trial that rigorously compares the accuracy of treatment decisions between a physician-only arm and an AI-assisted physician arm.
Conditions
- DME
- Retinal Vein Occlusion (RVO)
- Neovascular (Wet) Age-Related Macular Degeneration
Interventions
- OTHER
-
QiLin-assisted
A Comprehensive Deep Learning Model for Assisting the decision of anti-VEGF therapy: QiLin system
- OTHER
-
physician only, without QiLin assisted
without QiLin assisted
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Xiaodong Sun, PhD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-25
- Primary Completion
- 2026-07-01
- Completion
- 2026-10-15
Countries
- China
Study Locations
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