High-throughput Large-model-based AI-assisted Diagnosis Using OCT

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital

About this trial

This observational study aims to establish key technologies for high-throughput, large-model-based AI-assisted diagnosis using optical coherence tomography (OCT) and OCT angiography (OCTA). The study will collect real-world OCT/OCTA images and corresponding clinical information from patients with common blinding retinal and optic nerve diseases at Peking Union Medical College Hospital.

A high-throughput diagnostic framework based on large-scale artificial intelligence models will be developed and evaluated. The primary objective is to determine the diagnostic performance of the AI system, including its ability to identify diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopic choroidal neovascularization, and glaucoma-related optic nerve damage.

The results of this study are expected to support the development of standardized, efficient, and scalable AI-assisted diagnostic pathways for OCT imaging in clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patients of any age or sex who undergo OCT and/or OCT angiography (OCTA) examinations as part of routine clinical care at Peking Union Medical College Hospital.

Disqualifiers

None

Trial population

This study population consists of patients who undergo OCT and/or OCT angiography (OCTA) examinations as part of routine clinical care at Peking Union Medical College Hospital. Eligible participants are clinically diagnosed with one or more of the following conditions: diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopia with choroidal neovascularization, or glaucoma with optic nerve damage. Both retrospectively collected and prospectively enrolled patients are included. No healthy volunteers or experimental interventions are involved.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • No intervention

    Other intervention

    This observational study involves no experimental intervention. All OCT and OCTA examinations are performed as part of routine clinical care, and the study only analyzes retrospectively and prospectively collected imaging and clinical data to evaluate a large-model-based AI diagnostic system.

Treatment groups

2,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Diabetic Retinopathy Cohort1 intervention
Group B: Branch Retinal Vein Occlusion Cohort1 intervention
Group C: Central Retinal Vein Occlusion Cohort1 intervention
Group D: Age-related Macular Degeneration Cohort1 intervention
Group E: Pathologic Myopia with Choroidal Neovascularization Cohort1 intervention
Group F: Glaucoma Cohort1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic performance of the AI-assisted OCT/OCTA model (AUC for multi-disease classification)

Area under the receiver operating characteristic curve (AUC) of the high-throughput large-model-based OCT/OCTA diagnostic system for identifying major retinal and optic nerve diseases, including diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopic choroidal neovascularization, and glaucoma.

Time frame
Baseline imaging visit (time of image acquisition and model inference).

Secondary outcomes

1

Sensitivity and specificity of the AI-assisted OCT/OCTA model

Sensitivity and specificity of the AI system for detecting each target disease (diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopic choroidal neovascularization, and glaucoma) compared with masked clinician consensus.

Time frame
At the time of image acquisition and model inference (baseline imaging visit).
2

Agreement between AI-assisted diagnosis and clinician diagnosis

Level of agreement between the AI system's classification and the final clinical diagnosis by retina and glaucoma specialists, quantified using Cohen's kappa statistics or similar agreement measures.

Time frame
At the time of image acquisition and model inference (baseline imaging visit).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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