Diagnostic Performance of an AI-based Model for TCM Constitution Classification Using Ophthalmic Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

To evaluate the diagnostic performance of a multimodal deep learning model for identifying biased Traditional Chinese Medicine (TCM) constitutions using ophthalmic imaging

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: Participants aged between 18 and 60 years;

Chronic Systemic Diseases: Defined according to the standards of the United States National Center for Chronic Disease Prevention and Health Promotion and the "Healthy China 2030" planning outline issued by the State Council. These are characterized as conditions lasting one year or longer that require continuous medical care, limit daily activities, or both. The four major chronic diseases in China include:Cardiovascular and cerebrovascular diseases,Malignant neoplasms,Diabetes mellitus and Chronic respiratory diseases;

Cardiovascular and Cerebrovascular Diseases: This category includes:Hypertension: Stable hypertension without acute episodes, defined as systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or currently undergoing antihypertensive treatment.Coronary Heart Disease: Diagnosed based on a history of coronary heart disease or confirmed through imaging evidence such as coronary angiography or CT angiography.

Malignant Neoplasms: Participants with newly diagnosed, recurrent, metastatic malignant tumors, or those currently receiving specific treatments (e.g., chemotherapy, radiotherapy, immunotherapy), confirmed by histological or cytological examinations;

Disqualifiers

Incomplete Clinical Data Supporting Diagnosis: Participants for whom the clinical data necessary to substantiate the diagnosis are incomplete;

Significant Opacification of Other Ocular Optical Systems: Individuals presenting with pronounced obscurations in other ocular optical systems (e.g., severe corneal opacification, nuclear cataract grade IV or higher, severe vitreous hemorrhage or opacification) that impede the completion of comprehensive ocular examinations;

Acute Systemic Organic Diseases: Patients concurrently suffering from acute systemic organic conditions (such as acute infections or decompensated organ failure) that prevent participation in the constitution identification procedures;

Pregnancy or Lactation: Individuals who are pregnant or currently breastfeeding.

Trial population

Chronic systemic disease patients and healthy subjects from the Second Affiliated Hospital of Nanchang University.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • AI-based Ocular Diagnosis Model for TCM Constitutions

    Diagnostic test

    AI-based Ocular Diagnosis Model for Identifying Traditional Chinese Medicine (TCM) Constitutions

Treatment groups

1,024 Participants
are divided into 2 treatment groups
Group A: Patients with Chronic Systemic Diseases1 intervention
Group B: Healthy Control Group1 intervention

Trial outcomes

Primary outcomes

1

AUROC of AI-based model in identifying TCM Constitutions

The area under the receiver operating characteristic of AI-based model in identifying Traditional Chinese Medicine constitutions

Time frame
Day 0

Secondary outcomes

1

Sensitivity and specificity of AI-based model in identifying TCM Constitutions

Sensitivity and specificity of AI-based model in identifying Traditional Chinese Medicine constitutions

Time frame
Day 0

Other outcomes

Sponsors and contacts

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