Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients

December 25, 2025 updated by: Robert T. Chang, MD, Stanford University

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

Enrolling by invitation

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert T Chang, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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