Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LLM-based Education.
- Who it may be relevant to
- Registry conditions: Glaucoma, Eye Disorders, Visual Fields, Visual Field Tests. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients: A Randomized Controlled Trial
Overview
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.
Interventions
- Other LLM-based Education
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 frequenc
Primary outcome measures
- Humphrey Visual Field Test Taking Duration [Time frame: Same Day of Enrollment up to 2 hours]
Secondary outcome measures (5)
- Changes in False Positives and False Negatives (Reliability Indices) [Time frame: 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]
- Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8) [Time frame: 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]
- Second-tested eyes [Time frame: Same Day of enrollment up to 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Byers Eye Institute — Palo Alto
Identifiers
NCT: NCT07327242 · 82165