Меню
Набор скоро начнётся NCT07401459

A Multimodal AI Agent for Ophthalmic Clinical Decision Support

Без фазы С лечением Ophthalmology Large Language Models AI Agent Eye Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: EyeAgent AI system.
Кому может быть актуально
Состояния в реестре: Ophthalmology, Large Language Models, AI Agent, Eye Disease. Базовые параметры: 6 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Multicenter Randomized Controlled Trial of a Multimodal AI Agent for Ophthalmology Clinical Decision Support

Обзор

This study is a multicenter randomized controlled trial evaluating the effectiveness and safety of EyeAgent, a multimodal artificial intelligence (AI) agent designed to assist ophthalmologists in clinical decision-making. Participants will be recruited from ophthalmology clinics and hospitals in Hong Kong and mainland China. The AI agent acts as a digital co-pilot, analyzing patient images and clinical history to provide diagnostic and management recommendations. The trial aims to determine whether the use of the AI agent improves diagnostic accuracy, treatment decision-making performance, report generation, workflow efficiency, and user satisfaction compared to standard clinical practice.

Подробное описание

This multicenter, randomized controlled trial aims to evaluate the integration of EyeAgent, a multimodal artificial intelligence (AI) agent, in real-world clinical settings. The AI system is designed to support clinicians by analyzing patient data, including ocular images and electronic health records, to aid in image interpretation, diagnosis, and treatment planning.

A total of 300 participants will be randomly assigned to either an AI-assisted care arm or a standard care arm. In the AI-assisted arm, clinicians review the comprehensive report generated by AI agent as a supportive tool before finalizing their independent decisions. The study comprehensively measures diagnostic accuracy, the rate of inappropriate treatment decisions, report generation, workflow efficiency, and user questionnaire.

By comparing these two groups, the trial aims to provide robust evidence on the effectiveness and practical utility of AI-driven clinical decision support in ophthalmology, with the goal of enhancing both the quality and efficiency of patient care.

Вмешательства

  • Устройство EyeAgent AI system
    EyeAgent is a multimodal AI agent assistant for ophthalmology that integrates imaging, electronic health records, and curated clinical knowledge. In this arm, EyeAgent supports clinicians in clinical consultation, including report generation, diagnostic interpretation, and treatment planning.

Первичные конечные точки

  • Diagnostic accuracy rate [Срок оценки: Immediately after the intervention.]
  • Rate of inappropriate treatment decisions [Срок оценки: Immediately after the intervention.]
Вторичные конечные точки (4)
  • Report quality [Срок оценки: Within 1 month after enrollment.]
  • Clinician confidence [Срок оценки: Immediately after the intervention.]
  • Workflow efficiency [Срок оценки: During the index diagnostic session.]
  • Satisfaction and usability [Срок оценки: At the end of each clinician's participation period, approximately 2 months.]

Критерии участия

Критерии включения

  • Outpatient participants aged 6 to 75 years.
  • Participants who undergo ophthalmic examinations for medical purposes during the study period.
  • Participants who can produce clear ophthalmic images in both eyes.
  • Agree to participate in this study with written informed consent:
  • Participants aged 18 years or older provide their own consent.
  • Participants aged 6-17 years require consent from a parent or legal guardian.

Критерии исключения

  • Participants who are reluctant to participate in this study.
  • Participants presenting with acute or emergency ocular conditions requiring immediate intervention.
  • Participants with poor quality of ophthalmic images, including blurriness, artifacts, underexposure, or overexposure.
  • Other unsuitable reasons determined by the evaluators.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07401459 · PolyU-IRB-2025-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗