Ophthalmic Multimodal AI-Assisted Medical Decision-Making

NCT ID: NCT06755190

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-05-31

Brief Summary

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This is a multi-center, retrospective clinical study designed to evaluate the application and effectiveness of an AI-assisted medical decision support system, leveraging multimodal data fusion, in ophthalmic clinical practice.

Detailed Description

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Visual impairments significantly affect an individual's quality of life. Early screening, diagnosis, and treatment of ocular diseases are crucial for preventing the onset and progression of vision disorders. In clinical practice, ophthalmologists often need to integrate a wide range of patient data, including demographic information, medical history, biochemical markers such as blood glucose and lipid levels, risk factors, as well as various ophthalmic data, such as fundus images, OCT scans, and visual field tests, to make an accurate diagnosis and develop an appropriate treatment plan. In an era where precision and personalized medicine are at the forefront of healthcare, the early detection and diagnosis of eye diseases, as well as the selection of suitable diagnostic and therapeutic strategies at different stages of the disease, have become significant challenges in clinical settings. Recent advancements in medical imaging and analysis techniques have greatly enhanced the accuracy and effectiveness of ocular disease diagnosis. This study aims to develop an ophthalmic artificial intelligence-assisted decision-making system by integrating multimodal data from imaging and electronic medical records, in combination with deep learning techniques. The objective is to improve diagnostic accuracy, streamline clinical workflows, and provide more personalized treatment options for patients. Ultimately, this system seeks to enhance treatment outcomes and improve the overall quality of life for patients suffering from ocular diseases.

Conditions

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Ocular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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normal

patients who do not have the ocular diseases

No interventions assigned to this group

ocular diseases

patients who have ocular diseases

Diagnostic Test: AI-Based Diagnostic and Prognostic Model for Ocular Diseases

Intervention Type DIAGNOSTIC_TEST

This intervention involves an AI system that leverages multimodal data fusion to support the clinical decision-making and evaluation of ophthalmic diseases. It integrates multi-modal data, including fundus photography, optical coherence tomography (OCT), and patient clinical records, to provide real-time, precise, and personalized diagnostic support. Unlike other models, this system utilizes a longitudinal patient dataset to predict disease progression and treatment outcomes.Key distinguishing features include: 1. Multi-Modal Data Integration: Combines imaging, clinical, and genetic data for comprehensive analysis. 2. Predictive Capability: Offers advanced prognostic predictions, enabling personalized treatment plans. 3. Deep Learning Framework: Employs state-of-the-art deep learning algorithms for improved diagnostic accuracy and efficiency. 4. Real-World Validation: Validated using a large cohort of diverse patient data, ensuring generalizability and robustness.

Interventions

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Diagnostic Test: AI-Based Diagnostic and Prognostic Model for Ocular Diseases

This intervention involves an AI system that leverages multimodal data fusion to support the clinical decision-making and evaluation of ophthalmic diseases. It integrates multi-modal data, including fundus photography, optical coherence tomography (OCT), and patient clinical records, to provide real-time, precise, and personalized diagnostic support. Unlike other models, this system utilizes a longitudinal patient dataset to predict disease progression and treatment outcomes.Key distinguishing features include: 1. Multi-Modal Data Integration: Combines imaging, clinical, and genetic data for comprehensive analysis. 2. Predictive Capability: Offers advanced prognostic predictions, enabling personalized treatment plans. 3. Deep Learning Framework: Employs state-of-the-art deep learning algorithms for improved diagnostic accuracy and efficiency. 4. Real-World Validation: Validated using a large cohort of diverse patient data, ensuring generalizability and robustness.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1.All patients who have received treatment at multiple centers, including The Eye Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, ZhuHai Hospital, and Macau University of Science and Technology Hospital.

2.Availability of comprehensive electronic health records (EHR), including: Ophthalmic images (e.g., fundus photography, OCT, or slit-lamp images). Electronic medical records (e.g., diagnosis, treatment, and follow-up notes). Examination results (e.g., visual acuity, intraocular pressure, or laboratory tests). 3.Patients with a clear and confirmed diagnosis of one or more ocular diseases. 4.Patients with sufficient follow-up records to allow assessment of disease progression or prognosis, if applicable.

1. All ophthalmology patients who have previously received treatment at the Department of Ophthalmology, the Eye Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Zhuhai People's Hospital, and the University Hospital.
2. Availability of comprehensive electronic health records (EHR), including: Ophthalmic images (e.g., fundus photography, OCT, or slit-lamp images). Electronic medical records (e.g., diagnosis, treatment, and follow-up notes). Examination results (e.g., visual acuity, intraocular pressure, or laboratory tests).
3. Patients with a clear and confirmed diagnosis of one or more ocular diseases.
4. Patients with sufficient follow-up records to allow assessment of disease progression or prognosis, if applicable.

Exclusion Criteria

1. Incomplete or missing critical EHR components.
2. Cases with ambiguous or unverified diagnoses that cannot be clearly categorized.
3. Duplicated or redundant data from the same patient.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Eye Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kang Zhang

Chief Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kang Zhang, PhD.

Role: PRINCIPAL_INVESTIGATOR

The Eye Hospital of Wenzhou Medical University

Locations

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ZhuHai Hospital, zhuhai, guangdong

Zhuhai, Guangdong, China

Site Status RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Second Affiliated Hospital of Wenzhou Medical Universit

Wenzhou, Zhejiang, China

Site Status RECRUITING

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Macau University of Science and Technology Hospital

Macao, Macau, Macau

Site Status RECRUITING

Countries

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China Macau

Central Contacts

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Lan Wang, MD

Role: CONTACT

+86-0577-85397527

Facility Contacts

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Bingzhou Li

Role: primary

+86-0756-2222569

Cheng Tang, MD

Role: primary

+86-0577-55579999

Sian Liu, PhD.

Role: primary

+86-0577-88002888

Lan Wang, MD

Role: primary

+86-0577-85397527

Yang Liu, MD

Role: primary

+853-2882-1838

Other Identifiers

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Ophthalmic Multimodal AI

Identifier Type: -

Identifier Source: org_study_id

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