- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327242
Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients
Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients: A Randomized Controlled Trial
The purpose of this study is to evaluate whether a large language model (LLM)-based audiovisual educational tool improves the test time and reliability of standard automated perimetry (SAP) using the SITA Standard 24-2 protocol in English-speaking glaucoma patients.
Glaucoma is a disease that can lead to blindness if not properly monitored and treated. One of the most important tests for glaucoma is the visual field (VF) test, which checks how well a person can see in different directions. However, this test is difficult for many patients to perform correctly, especially if they don't fully understand how it works. Unreliable test results can lead to repeated visits, wasted time, and incorrect treatment decisions.
This study is testing whether a computer-based educational tool, powered by artificial intelligence (AI), can help patients better understand the VF test before taking it. The study team want to see if this helps make the test results more reliable. The goal is to improve the quality of care while reducing the burden on patients and clinic staff.
The LLMs will be used as an educational tool only, not for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94303
- Byers Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (≥18 years) with a diagnosis or suspected diagnosis of glaucoma
- English-speaking
- Scheduled for Humphrey visual field testing 24-2 SITA standard
- Having at least 2 prior visual field tests , with the most recent prior test performed using the 24-2 SITA Standard strategy within 2 years before enrollment.
- Best corrected visual acuity in both eyes ≥ 20/40
Exclusion Criteria:
- Unable to comply with study and questionnaires
- Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care
Patients will be informed of the standard protocol of Humphrey visual field testing by visual field technicians prior to their testing.
Their education and knowledge will primarily come from the technicians themselves.
|
|
|
Experimental: LLM-based Education + Standard of Care
Participants will receive audiovisual education powered by a large language model (LLM) before their visual field test, in addition to the standard of care information provided by the Humphrey visual field technicians.
|
Participants will receive audiovisual education powered by a large language model (LLM) before their visual field test.
The LLM will be presented using a 10 inch tablet or laptop device by a trained research team member.
The interaction is intended to be self-guided, with no interference from the staff unless the LLM displays incorrect or "hallucinated" content.
In such cases, the research staff will immediately correct any misinformation and record the occurrence, including details and frequency of the hallucination, for quality monitoring.
The LLM module will deliver instructions, simulate the visual field test experience, and include a brief knowledge check.
This LLM-based education is for research purposes only.
Afterward, participants will proceed to their scheduled visual field test, which will include standard support from the clinic perimetrist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Humphrey Visual Field Test Taking Duration
Time Frame: Same Day of Enrollment up to 2 hours
|
Test duration of Humphrey visual field test of the first tested eye will be compared to the same first tested eye of the study participant's previous test as a continuous variable.
|
Same Day of Enrollment up to 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: Same Day of Enrollment up to 2 hours
|
4-point ordinal Likert-type response options.
The total CSQ 8 score will be used as a continuous outcome, with higher scores indicating greater satisfaction.
|
Same Day of Enrollment up to 2 hours
|
|
Changes in False Positives and False Negatives (Reliability Indices)
Time Frame: Same Day of Enrollment up to 2 hours
|
Change in false positive percentage and false negative percentage for the first tested eye between the most recent prior unreliable Humphrey visual field and the study visit field, comparing intervention and control groups.
Each index will be analyzed as a continuous variable, with higher values indicating worse reliability.
|
Same Day of Enrollment up to 2 hours
|
|
Proportion of Visual Field Test Standard Reliability
Time Frame: Same Day of Enrollment up to 2 hours
|
Proportion of participants whose first tested eye produces a reliable Humphrey visual field at the study visit, comparing AI based education plus standard perimetrist instruction versus standard perimetrist instruction alone.
Reliability will be defined a priori using standard criteria, for example fixation losses less than 20 percent, false positives less than 15 percent, and false negatives less than 15 percent on the same day visual field report.
The first tested eye at the study visit will be used for the primary analysis.
|
Same Day of Enrollment up to 2 hours
|
|
Scores on the brief post-education knowledge assessment
Time Frame: Same day of enrollment up to 2 hours
|
Score on a brief post education knowledge assessment about Humphrey visual field testing, administered immediately after the study visit test.
The score will be calculated as the number or percentage of correct responses on a clinical visual field questionnaire on a nominal scale with response options such as yes, no, and not sure.
Higher scores indicate better knowledge.
|
Same day of enrollment up to 2 hours
|
|
Second-tested eyes
Time Frame: Same Day of enrollment up to 2 hours
|
Test results of the second eye tested in the same session during the Humphrey visual field test (to explore effects of fatigue, learning, or test order). For participants who undergo testing in both eyes during the same session, the proportion of reliable visual fields for the second tested eye at the study visit, using the same predefined reliability criteria as the primary outcome. Secondary analyses will also evaluate false positive and false negative percentages for the second tested eye and their change from the most recent prior unreliable Humphrey visual field test. |
Same Day of enrollment up to 2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert T Chang, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glaucoma
-
Hospices Civils de LyonRecruitingOpen-angle Glaucoma | Glaucoma Eye | Pigmentary Glaucoma | Closed-Angle Glaucoma | Pseudo Exfoliative SyndromeFrance
-
Imperial College Healthcare NHS TrustIRIDEX CorporationNot yet recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma Secondary | Glaucoma Traumatic | Glaucoma Uveitic
-
Wills EyeIOP OphthalmicsTerminatedPrimary Open Angle Glaucoma | Neovascular Glaucoma | Uveitic Glaucoma | Pseudoexfoliation Glaucoma | Primary Angle Closure Glaucoma | Pigmentary Glaucoma | Traumatic GlaucomaUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedGlaucoma | Glaucoma, Open-Angle | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma and Ocular Hypertension | Glaucoma, Uncompensated | Glaucoma SecondaryCanada
-
Pro Top & Mediking Company LimitedCompletedOpen Angle Glaucoma | Neovascular Glaucoma | Angle Closure Glaucoma | Uveitis Glaucoma | Young Age Glaucoma | High Risk PatientEstonia
-
Isfahan University of Medical SciencesActive, not recruitingAngle Closure Glaucoma | Glaucoma EyeIran
-
University of MiamiAbbVieRecruitingOcular Hypertension | Glaucoma | Open-Angle Glaucoma | Glaucoma SuspectUnited States
-
Stanford UniversityNot yet recruitingPrimary Open Angle Glaucoma | Open Angle Glaucoma | Low Tension Glaucoma | Pseudoexfoliation Glaucoma | Pigmentary GlaucomaUnited States
-
Ngoc Nguyen Inc.Alcon ResearchNot yet recruitingGlaucoma | Glaucoma, Open Angle | Open Angle Glaucoma (OAG) | Normal Tension Glaucoma (NTG)United States
-
Jonathon MyersGlaukos CorporationRecruitingOpen Angle Glaucoma | Pseudoexfoliation Glaucoma | Pigmentary GlaucomaUnited States
Clinical Trials on LLM-based Education
-
Huseyin KocakgolNot yet recruiting
-
Stanford UniversityEnrolling by invitationIntraocular Lens | Cataract Extraction | Cataract Surgery | Eye Disorders | Cataract and IOL Surgery | Cataract Surgery ExperienceUnited States
-
University of MichiganNot yet recruitingCaregiversUnited States
-
The University of Texas Health Science Center,...Health Science Education Small Grants ProgramNot yet recruiting
-
Kyoto University, Graduate School of MedicineFitting Cloud Inc.CompletedClinical Documentation | Large Language Model | Clinician-in-the-loopJapan
-
Beijing Anzhen HospitalNot yet recruitingCongenital Heart Disease | Aortic Aneurysm | Aortic Dissection | Heart Valve Disease | Coronary Artery Bypass Grafting | Cardiac Surgical ProceduresChina
-
ITALO EUGENIO SOUZA GADELHA DE ABREUCompletedDeep Vein Thrombosis | Artificial Intelligence | Clinical Decision Support Systems | Pulmonary Thromboembolisms | Superficial ThrombophlebitisBrazil
-
Erasmus Medical CenterCompleted
-
The Hong Kong Polytechnic UniversityCompletedMyopia | Large Language ModelChina
-
The University of Hong KongRecruitingMetabolic Dysfunction-Associated Steatotic Liver Disease | Metabolic Alcohol-Related Liver DiseaseHong Kong