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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Humphrey Visual Field Test Taking Duration [Срок оценки: Same Day of Enrollment up to 2 hours]

Вторичные конечные точки (5)

• Changes in False Positives and False Negatives (Reliability Indices) [Срок оценки: Same Day of Enrollment up to 2 hours]
• Proportion of Visual Field Test Standard Reliability [Срок оценки: Same Day of Enrollment up to 2 hours]
• Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: Same Day of Enrollment up to 2 hours]
• Scores on the brief post-education knowledge assessment [Срок оценки: Same day of enrollment up to 2 hours]
• Second-tested eyes [Срок оценки: Same Day of enrollment up to 2 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Byers Eye Institute — Palo Alto

Идентификаторы

NCT: NCT07327242 · 82165

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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