NCT07327242

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

December 5, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 5, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

HVFhumphrey visual field testGlaucomaLLMAIGPTChatGPTEducation

Outcome Measures

Primary Outcomes (1)

  • Humphrey Visual Field Test Taking Duration

    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 Outcomes (5)

  • Changes in False Positives and False Negatives (Reliability Indices)

    Same Day of Enrollment up to 2 hours

  • Proportion of Visual Field Test Standard Reliability

    Same Day of Enrollment up to 2 hours

  • Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8)

    Same Day of Enrollment up to 2 hours

  • Scores on the brief post-education knowledge assessment

    Same day of enrollment up to 2 hours

  • Second-tested eyes

    Same Day of enrollment up to 2 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

LLM-based Education + Standard of Care

EXPERIMENTAL

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.

Other: LLM-based Education

Interventions

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.

LLM-based Education + Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

GlaucomaEye Diseases

Condition Hierarchy (Ancestors)

Ocular Hypertension

Study Officials

  • Robert T Chang, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The research personnel consenting and enrolling potential study participants and the visual field testing technicians will be blinded to the next study group the potential study participant will be put in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Intervention Group: 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. * Control Group: Participants will receive standard-of-care perimetrist instructions only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

December 5, 2025

First Posted

January 8, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations