NCT06755060

Ophthalmic AI-Assisted Medical Decision-Making

A Study on Ophthalmic Multimodal AI-Assisted Medical Decision-Making Based on Imaging and Electronic Medical Record Data

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100,000 (estimated)
• Sponsor: The Eye Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This is a multi-center, prospective 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

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

• Ocular Diseases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	AI-associated strategy	The intervention in this study involves an AI system that leverages multimodal data fusion to support the clinical decision-making and evaluation of ophthalmic diseases. Patients in the intervention group will undergo standard ophthalmic examinations, with clinical decisions guided by the recommendations generated by the AI system. In contrast, patients in the control group will receive only standard ophthalmic examinations and treatment, without the support of AI-assisted decision-making tools.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-01-01
• Last updated: 2025-08-20

Locations

5 sites across 2 countries: China, Macau