Neovascular Age-Related Macular Degeneration (nAMD)LMU ASSISTNCT06817915
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)
A study testing AI assisted assessment of SD-OCT scans in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Johannes Schiefelbein at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD)
- What is being tested?
- AI assisted assessment of SD-OCT scans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not an Ophthalmologist.
- Does not have time to participate in the estimated project duration of 30 minutes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
LMU Klinikum
Munich, Bavaria, 80336
Clinical Project Manager, +491749286564, assistsurvey@deepeye-medical.com
Siegfried Priglinger, Prof Dr med
About this study
Official title: 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
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.
Read the 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.
- Being tested
- AI assisted assessment of SD-OCT scans
- Keywords
- Decison-making, AI-Assisted treatment, artificial intelligence, clinical decision support, ophthalmology, SD-OCT, neovascular age-related macular degeneration, nAMD, anti-VEGF, explainable AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI assisted assessment of SD-OCT scansBehavioural
AI 2nd opinion report on nAMD treatment planning
| Study group | Role | What they receive |
|---|---|---|
| AI 2nd opinion assisted assessment of SD-OCT scan | Experimental | Ophthalmologists assess patient SD-OCT scans before and after reviewing AI-2nd opinion reports Receives: Behavioral: AI assisted assessment of SD-OCT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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?
Measured: 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?
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start30 Jan 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Survey
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Schiefelbein
- Sponsor type
- University, hospital or other
- Collaborators
- Deepeye Medical GmbH, Technomics Research, M3 Macula Monitor Muenster
- Responsible party
- Sponsor-investigator, Johannes Schiefelbein, LMU Klinikum
- Investigators
- Director the Eye Clinic, Study director, LMU Klinikum Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817915
- Sponsor's protocol ID
- 2301LMUASSIST
- Acronym
- LMU ASSIST
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 34172943
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06817915
- Acronym / sponsor ID
- LMU ASSIST / 2301LMUASSIST
- Keywords
- Decison-making, AI-Assisted treatment, artificial intelligence, clinical decision support, ophthalmology, SD-OCT, neovascular age-related macular degeneration, nAMD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johannes SchiefelbeinUniversity, hospital or other
- Collaborators
- Deepeye Medical GmbH, Technomics Research, M3 Macula Monitor Muenster
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Survey
| Arm | Type | Receives |
|---|---|---|
| AI 2nd opinion assisted assessment of SD-OCT scan | Experimental | Behavioral: AI assisted assessment of SD-OCT scansOphthalmologists assess patient SD-OCT scans before and after reviewing AI-2nd opinion reports |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Not an Ophthalmologist.
- Does not have time to participate in the estimated project duration of 30 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI assisted assessment of SD-OCT scansAI 2nd opinion report on nAMD treatment planning | Behavioural | AI 2nd opinion assisted assessment of SD-OCT scan |
Primary outcome
Ophthalmologist's Treatment Decision
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.
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
3 secondary outcomes
Performance Accuracy
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 34172943Chopra 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Director the Eye Clinic study director
LMU Klinikum Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI assisted assessment of SD-OCT scans in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Johannes Schiefelbein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+491749286564, assistsurvey@deepeye-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ophthalmologist's Treatment Decision (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06817915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.