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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
100
AI 2nd opinion report on nAMD treatment planning
LMU Klinikum
Munich, Bavaria, Germany
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
Time frame: There is only one survey filled out by the participant. In this survey, only one time point when participant views the SD-OCT and AI 2nd opinion report and fills out the survey questions.
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?
Time frame: There is only one survey filled out by the participant. In this survey, only one time point when participant views the SD-OCT and AI 2nd opinion report and fills out the survey questions.
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?
Time frame: There is only one survey filled out by the participant. In this survey, only one time point when participant views the SD-OCT and AI 2nd opinion report and fills out the survey questions.
Exploratory AI-CDS report Impact on Decision Making
impact of AI-CDS report on ophthalmologist's decision-making survey
Time frame: There is only one survey filled out by the participant. In this survey, only one time point when participant views the SD-OCT and AI 2nd opinion report and fills out the survey questions.
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