Ophthalmic AI-Assisted Medical Decision-Making

NCT06755060 | Recruiting DMC

• 1 other identifier: Ophthalmic AI
• Study Type: interventional
• Target: 100,000
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Ocular Diseases

Keywords

ocular diseases; Ophthalmic Multimodal AI-Assisted Medical Decision-Making; Artificial Intelligence

Outcome Measures

Primary Outcomes (9)

• Area Under the Curve (AUC)

  AUC of the ROC curve, used to quantify diagnostic accuracy. No unit (a ratio or percentage, typically expressed as a number between 0 and 1).

  2 years

• Sensitivity

  Sensitivity (also called True Positive Rate) is a measure of how well a model identifies positive instances. It is defined as the proportion of actual positive cases correctly identified by the model. No unit (a ratio or percentage, typically expressed as a percentage).

  2 years

• Specificity

  Specificity (also called True Negative Rate) measures the proportion of actual negative cases correctly identified by the model. No unit (a ratio or percentage, typically expressed as a percentage).

  2 years

• Accuracy

  Accuracy measures the proportion of all correct predictions (true positives and true negatives) out of the total number of cases evaluated by the model. No unit (a ratio or percentage, typically expressed as a percentage).

  2 years

• False Positive Rate

  False Positive Rate (FPR) measures the proportion of actual negative cases that are incorrectly identified as positive by the model. No unit (a ratio or percentage, typically expressed as a percentage).

  2 years

• False Negative Rate

  False Negative Rate (FNR) measures the proportion of actual positive cases that are incorrectly identified as negative by the model. No unit (a ratio or percentage, typically expressed as a percentage).

  2 years

• Postoperative Complication Rate

  Percentage (%) of patients experiencing postoperative complications.

  2 years

• Recurrence Risk Rate

  Percentage (%) of patients experiencing recurrence during the follow-up period.

  2 years

• Survival Rate

  Percentage (%) of patients alive, calculated using Kaplan-Meier survival curves.

  2 years

Secondary Outcomes (9)

• System Usability Score

  2 years

• AI System Response Time

  2 years

• System Failure Rate

  2 years

• User Interface Design Satisfaction

  2 years

• Patient Satisfaction Score

  2 years

Study Arms (2)

AI-assisted medical decision-making

EXPERIMENTAL

Patients in the intervention group will receive AI-assisted medical decision-making based on multimodal data.

Combination Product: AI-associated strategy

Traditional medical decision-making

NO INTERVENTION

Patients in the control group will receive traditional medical decision-making, where treatment and diagnostic decisions are made solely by the attending physician based on clinical judgment, without the support of AI-assisted system.

Interventions

AI-associated strategy COMBINATION_PRODUCT

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.

AI-assisted medical decision-making

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ophthalmic Disease Diagnosis: Eligible patients must have a diagnosis of one or more ophthalmic conditions, with the diagnosis confirmed by a qualified ophthalmologist.
• Imaging and Clinical Data Requirements: Patients must be able to provide complete ophthalmic imaging data and electronic medical records (EMR) that are comprehensive and accessible for the purposes of the study.
• Informed Consent: All patients, or their legal representatives in the case of minors or individuals unable to provide informed consent, must sign a consent form that clearly outlines the study's objectives, procedures, potential risks and discomforts, data usage, and the rights and responsibilities of participants. In the case of minors or those unable to consent, informed consent must be obtained from the patient's legal guardian.
• Treatment Adherence: Participants must demonstrate the ability to understand and adhere to the study's requirements, including compliance with follow-up visits, examination schedules, and treatment recommendations. Patients must agree to participate in regular assessments and data collection, including imaging exams, laboratory tests, and follow-up evaluations as required by the study protocol.

You may not qualify if:

• Serious Systemic Diseases: Patients with serious systemic illnesses that may interfere with the treatment of ocular diseases, impact the effectiveness of the intervention, or complicate the interpretation of study outcomes.
• Prior Exposure to Study Interventions: Patients who have previously undergone the intervention being studied or participated in other experimental treatments within ongoing clinical trials, as this may introduce bias or confound the study results.
• Incomplete Imaging or Clinical Data: Patients who are unable to provide complete or adequate ophthalmic imaging data or lack a comprehensive electronic medical record (EMR), which are essential for the integrity of the study data.
• Pregnancy or Lactation: Pregnant or breastfeeding women, for whom there may be potential risks associated with ocular treatment or imaging procedures. Such cases will be evaluated on an individual basis to ensure patient safety.
• Mental Health or Cognitive Impairment: Patients diagnosed with significant mental health disorders or cognitive impairments that prevent them from fully understanding the nature and risks of the study, or from complying with the treatment regimen and follow-up procedures.
• Drug Allergies or Severe Reactions: Patients with known allergies or severe adverse reactions to any medications or ophthalmic treatments likely to be used during the study, which could pose a health risk to the patient.
• Current Participation in Other Clinical Trials: Patients who are concurrently involved in other interventional clinical trials (especially those related to ophthalmology), as this may lead to conflicting treatments or interfere with the assessment of the study's outcomes.
• Inability to Comply with Follow-up Requirements: Patients who, due to logistical, health-related, or personal factors, are unable to comply with the required follow-up visits, treatment regimens, or data collection, which are essential for the study's longitudinal analysis.

Sponsors & Collaborators

• The Eye Hospital of Wenzhou Medical University: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• ZhuHai Hospital: collaborator
• Macau University of Science and Technology Hospital: collaborator

Study Sites (5)

ZhuHai Hospital

Zhuhai, Guangdong, China

RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Macau University of Science and Technology Hospital

Macao, Macau

RECRUITING

Central Study Contacts

Lan Wang, MD

CONTACT

+86-0577-85397527; wl2832300533@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientist

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 1, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4); MA (1)