NCT06817915

This Project At LMU Looks At How Using AI 2nd Opinion Report to Analyze Retinal Eye Scans Impact Doctors' Decisions About Treatment for Patients with a Specific Eye Disease (nAMD)

LMU Project on the Impact of Reviewing AI Annotated SD-OCT Therapy Assistance Reports on Ophthalmologists' Treatment Decision-making for Anti-VEGF Therapy in NAMD Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Johannes Schiefelbein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a research plan from the University of Munich (LMU) that aims to study how the use of AI reports can impact ophthalmologists' decisions regarding treatment for patients with neovascular age-related macular degeneration (nAMD). This disease is a leading cause of vision loss, and while anti-VEGF treatments are effective, they require careful monitoring and retreatment decisions to maximize benefits. The study will involve up to 1000 ophthalmologists with varying levels of expertise. These ophthalmologists will review SD-OCT scans and make treatment decisions before and after reviewing AI-generated reports. The primary objective is to compare these decisions and see how the AI reports influence them. Secondary objectives include assessing the accuracy and safety of the AI reports.

Detailed description

This research project at LMU delves into the intersection of artificial augmentation and ophthalmology, specifically focusing on how AI-generated 2nd opinion reports can aid in the treatment planning of neovascular age-related macular degeneration (nAMD). The project will involve a diverse group of up to 1000 ophthalmologists, categorized into six user groups based on their expertise, ranging from residents to seasoned retina specialists. The core of the research involves assessing the impact of AI-generated 2nd opinion reports on ophthalmologists' treatment decisions for nAMD. Participants will review SD-OCT scans and make initial treatment decisions. Subsequently, they will review AI-generated reports for the same scans and have the opportunity to revise their decisions. This process aims to evaluate the influence of AI insights on clinical judgment. The project will be conducted virtually, with participants enrolling online from various countries. Data collection will be facilitated through an electronic system, ensuring efficiency and security. Statistical analysis will primarily involve descriptive statistics to summarize the findings. The results of the study will be disseminated through publication in a peer-reviewed journal.

Conditions

• Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
BEHAVIORAL	AI assisted assessment of SD-OCT scans	AI 2nd opinion report on nAMD treatment planning

Timeline

• Start date: 2025-01-30
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: Germany