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 | Not Yet Recruiting

• 1 other identifier: 2301LMUASSIST
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Keywords

Decison-making; AI-Assisted treatment; artificial intelligence; clinical decision support; ophthalmology; SD-OCT; neovascular age-related macular degeneration; nAMD; anti-VEGF; explainable AI

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Secondary Outcomes (3)

• Performance Accuracy

  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

  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

  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.

Study Arms (1)

AI 2nd opinion assisted assessment of SD-OCT scan

EXPERIMENTAL

Ophthalmologists assess patient SD-OCT scans before and after reviewing AI-2nd opinion reports

Behavioral: AI assisted assessment of SD-OCT scans

Interventions

AI assisted assessment of SD-OCT scans BEHAVIORAL

AI 2nd opinion report on nAMD treatment planning

AI 2nd opinion assisted assessment of SD-OCT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Not an Ophthalmologist.
• Does not have time to participate in the estimated project duration of 30 minutes.

Sponsors & Collaborators

• Johannes Schiefelbein: lead
• Deepeye Medical GmbH: collaborator
• Technomics Research: collaborator
• M3 Macula Monitor Muenster: collaborator

Study Sites (1)

LMU Klinikum

Munich, Bavaria, 80336, Germany

Location

Related Publications (1)

• Chopra R, Preston GC, Keenan TDL, Mulholland P, Patel PJ, Balaskas K, Hamilton RD, Keane PA. Intravitreal injections: past trends and future projections within a UK tertiary hospital. Eye (Lond). 2022 Jul;36(7):1373-1378. doi: 10.1038/s41433-021-01646-3. Epub 2021 Jun 25.

  PMID: 34172943 BACKGROUND

Study Officials

• Director the Eye Clinic

  LMU Klinikum Eye Clinic

  STUDY DIRECTOR

Central Study Contacts

Clinical Project Manager

CONTACT

+491749286564; assistsurvey@deepeye-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Project Lead

Model Details: Survey

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: January 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

DE (1)