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Clinical Trials in Germany / NCT06817915
Starting soon Not applicable

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)

NCT06817915 · tracked via the Priya Life Science Germany tracker
Sponsor
Johannes Schiefelbein
Phase
Not applicable
Started
2025-01-30
Last updated
2025-02-10

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD)

Investigational drug(s) / intervention(s)

AI assisted assessment of SD-OCT scans

AI assisted assessment of SD-OCT scans: AI 2nd opinion report on nAMD treatment planning

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Electronically consented to the informed consent form (eICF) * Criteria to be included in one of the following six Ophthalmology user groups: Group 1 Non-retina specialist Group: Ophthalmology, completed ophthalmology residence with no or another subspecialty other than retina (e.g., Glaucoma, refractive, etc) Group 2 Resident Group: \<5 years in residency in ophthalmology Group 3 Fellow Group: Retina specialist in training Group: in fellowship in vitreoretinal medicine, medical retina Group 4 Retina specialist Group: completed retina training, regular requalification Group 5 Junior reader Group: have already gained experience in the reporting clinical routine with the diagnostics in question and completed the initial certification process at an Image and Reading Center (acc. to centre's SOP) Group 6 Senior reader Group: specialist with several years of experience in the relevant field or have completed at least 3 years of residency training. Completed the certification process at the Image and Reading Center (acc. to centre's SOP) Exclusion Criteria: * Not an Ophthalmologist. * Does not have time to participate in the estimated project duration of 30 minutes.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
LMU Klinikum Munich Bavaria

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06817915 on ClinicalTrials.gov ↗ ← All trials in Germany