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Enrolling by Invitation

NCT Number: NCT07327242

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Eye Disorders Ocular Hypertension Visual Field Tests Visual Fields

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute

Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLM-based Education

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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