AI-assisted decision-making for eye diseases

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

This study is testing whether an AI tool can help eye doctors make better decisions about diagnosing and treating eye diseases to improve patient care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100000 (estimated)
• Sex: All
• Sponsor: The Eye Hospital of Wenzhou Medical University (Academic / other)
• Locations: 5 sites (Zhuhai, Guangdong and 4 other locations)
• Trial ID: NCT06755060 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of an AI-assisted medical decision support system in ophthalmology, utilizing multimodal data fusion to enhance diagnosis and treatment of ocular diseases. By integrating various patient data, including imaging and electronic medical records, the study aims to improve diagnostic accuracy and streamline clinical workflows. The approach leverages deep learning techniques to provide personalized treatment options, ultimately enhancing patient outcomes and quality of life. The study is conducted across multiple centers to gather diverse data and validate the AI system's performance.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with one or more ophthalmic conditions who can provide comprehensive imaging and medical records.

Not a fit: Patients without a confirmed diagnosis of ocular diseases or those unable to provide the necessary imaging and clinical data may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the early detection and treatment of ocular diseases, leading to better vision outcomes for patients.

How similar studies have performed: Other studies have shown promising results with AI-assisted approaches in medical decision-making, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age Criteria: No age restrictions apply for inclusion in the study.
2. Ophthalmic Disease Diagnosis: Eligible patients must have a diagnosis of one or more ophthalmic conditions, with the diagnosis confirmed by a qualified ophthalmologist.
3. 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.
4. 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.
5. 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.
6. Clinical Physician Assessment: The attending physician must determine that the patient meets all inclusion criteria and has the capacity to comply with the necessary treatment, diagnostic tests, and follow-up protocols throughout the study duration.

Exclusion Criteria:

1. Acute or Severe Ocular Diseases: Patients with acute ocular conditions requiring immediate medical intervention, which necessitate exclusion from interventional studies due to the urgency of their treatment.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. Other Clinical Exclusions: Patients whose participation, based on the clinical judgment of the treating physician, may not be in their best interest due to their health condition or other factors, or who may experience adverse outcomes from participating in the study.

Where this trial is running

Zhuhai, Guangdong and 4 other locations

• ZhuHai Hospital — Zhuhai, Guangdong, China (Recruiting)
• First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• The Eye Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• Macau University of Science and Technology Hospital — Macao, Macau (Recruiting)

Study contacts

• Study coordinator: Lan Wang, MD

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