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.
Electronically consented to the informed consent form (eICF)
Not an Ophthalmologist.
Does not have time to participate in the estimated project duration of 30 minutes.
Single group
AI assisted assessment of SD-OCT scans
BehavioralAI 2nd opinion report on nAMD treatment planning
Ophthalmologist's Treatment Decision
The number and percentage of initial treatment decisions that stayed the same after their review of the AI-CDS report The number and percentage of initial decisions that changed after their review of the AI-CDS report
Performance Accuracy
The number and percentage of correct assessments (accuracy) made by AI-CDS report vs image grading/reading center (M³ Macula Monitor Münster) assessment (control / gold standard / ground truth) The percentage of correct assessments (accuracy) made by each of the 6 user group vs. image grading and reading center (M³ Macula Monitor Münster) assessment (control / gold standard / ground truth). How often is the AI-CDS report correct? How often is each of the 6 user groups correct after viewing just the SD-OCT image? Intra-rater reliability: How often are ophthalmologists (each user group) right/wrong after viewing AI-CDS report and made any decision changes?
Safety prediciton assessment
Yes/No prediction rates If an ophthalmologist is correct and AI-CDS report incorrect, how often does AI-CDS report mislead? Whether false-positive or false-negative? If an ophthalmologist is wrong and AI-CDS report correct, how often does AI-CDS report correct? Whether false-positive or false-negative?
Exploratory AI-CDS report Impact on Decision Making
impact of AI-CDS report on ophthalmologist's decision-making survey
Click on the lead sponsor to view all of their trials.
Johannes Schiefelbein
Lead sponsor
LMU Klinikum
Sponsor institution
Deepeye Medical GmbH
Collaborator
Technomics Research
Collaborator
M3 Macula Monitor Muenster
Collaborator
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