Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID06755060

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

Led by The Eye Hospital of Wenzhou Medical University · Updated on 2025-08-20

100000

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

T

The Eye Hospital of Wenzhou Medical University

Lead Sponsor

F

First Affiliated Hospital of Wenzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Visual impairments can greatly reduce quality of life, making early screening, diagnosis, and treatment of eye diseases critical to prevent vision loss. This research aims to develop an AI-assisted medical decision support system that combines multiple types of patient data, including imaging and electronic medical records, using deep learning methods. The goal is to improve diagnosis accuracy, personalize treatment, and enhance outcomes for patients with ocular diseases. The study compares two groups: one receiving AI-assisted medical decision-making that uses integrated multimodal data, and another receiving traditional decision-making by physicians without AI support. Patients in both groups undergo standard ophthalmic exams. The AI system will provide recommendations to guide treatment and diagnosis in the intervention group, while the control group relies on physician judgment alone. Participants will be evaluated over two years with assessments including imaging, lab tests, and follow-up visits. Researchers will measure diagnostic accuracy through metrics like sensitivity, specificity, and false positive/negative rates, as well as patient satisfaction, system usability, and treatment adherence. Safety outcomes such as complication and recurrence rates will also be monitored, aiming to streamline clinical workflow and improve quality of life for those with eye diseases.

CONDITIONS

Brief Title

Ophthalmic AI-Assisted Medical Decision-Making

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • No age restrictions apply for inclusion.
  • Diagnosis of one or more ophthalmic diseases confirmed by a qualified ophthalmologist.
  • Ability to provide complete ophthalmic imaging data and accessible electronic medical records.
  • Signed informed consent form by the patient or legal representative.
  • Ability to understand and adhere to study requirements, including follow-up visits and treatment recommendations.
  • Attending physician confirms patient meets all inclusion criteria and can comply with study protocols.
Not Eligible

You will not qualify if you...

  • Acute ocular diseases requiring emergency treatment.
  • Serious systemic illnesses affecting ocular treatment or study outcomes.
  • Previous exposure to the study intervention or participation in other experimental treatments.
  • Incomplete or inadequate ophthalmic imaging data or electronic medical records.
  • Pregnancy or breastfeeding unless evaluated safe on an individual basis.
  • Significant mental health or cognitive impairments preventing study compliance.
  • Known allergies or severe reactions to medications or treatments used in the study.
  • Current participation in other interventional clinical trials, especially related to ophthalmology.
  • Inability to comply with follow-up visits or treatment regimens.
  • Other clinical reasons determined by the treating physician that may negatively affect participation or safety.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 years

Participants undergo either AI-assisted or traditional ophthalmic medical decision-making based on multimodal imaging and electronic medical record data to guide their clinical care.

Regular visits as per ophthalmic examination schedules during the treatment period

Trial Site Locations

Total: 5 locations

1

ZhuHai Hospital

Zhuhai, Guangdong, China

Actively Recruiting

2

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

3

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

4

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Actively Recruiting

5

Macau University of Science and Technology Hospital

Macao, Macau

Actively Recruiting

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Research Team

L

Lan Wang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Frequently Asked Questions

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