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

November 18, 2025 updated by: Peking Union Medical College Hospital

Study on Key Technologies for High-throughput Large-model-based AI-assisted Diagnosis Using OCT

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study investigates key technologies for high-throughput, large-model-based AI-assisted diagnosis using optical coherence tomography (OCT) and OCT angiography (OCTA). OCT/OCTA imaging has become an essential non-invasive tool for detecting and monitoring retinal and optic nerve diseases, yet manual interpretation remains time-consuming, experience-dependent, and limited by inter-observer variability. Recent advances in large artificial intelligence models provide an opportunity to develop scalable, generalizable diagnostic tools that can process large multimodal datasets and support clinical decision-making.

This observational study will enroll patients who undergo routine OCT and/or OCTA examinations at Peking Union Medical College Hospital and who are diagnosed with one or more of the following conditions: diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopic choroidal neovascularization, or glaucoma with optic nerve damage. The study will include both retrospectively collected and prospectively acquired imaging and clinical data, following standardized quality control and data-management procedures.

The high-throughput diagnostic framework will be trained and validated using large-scale image and clinical datasets. Primary outcomes include diagnostic performance metrics such as the area under the receiver operating characteristic curve (AUC). Secondary outcomes include sensitivity, specificity, and lesion-level or structural feature assessment when applicable. No experimental intervention will be introduced, and all imaging and clinical evaluations will follow standard clinical care.

The study aims to produce a robust, clinically relevant benchmark for large-model-based AI systems in OCT/OCTA interpretation and provide technical support for future integration of AI-assisted diagnostic tools into routine ophthalmic practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.

    2. Clinical diagnosis of at least one of the following conditions: Diabetic retinopathy, Branch retinal vein occlusion, Central retinal vein occlusion, Age-related macular degeneration, Pathologic myopia with choroidal neovascularization and Glaucoma with optic nerve damage.

    3. Imaging quality sufficient for analysis based on predefined OCT/OCTA quality control criteria.

    4. Ability to provide informed consent (for prospective participants), or availability of medical records that meet institutional ethical requirements (for retrospective data).

Exclusion Criteria:

- 1. Poor-quality OCT/OCTA images that do not meet analysis standards (e.g., severe motion artifacts, media opacity, incomplete scans).

2. Patients unable to cooperate with standard ophthalmic imaging procedures. 3. Any condition judged by investigators to preclude accurate imaging evaluation or reliable diagnostic interpretation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Diabetic Retinopathy Cohort
Patients undergoing routine OCT/OCTA examinations with clinically diagnosed diabetic retinopathy.
Other: No 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.
Branch Retinal Vein Occlusion Cohort
Patients with BRVO receiving standard clinical imaging evaluation.
Other: No 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.
Central Retinal Vein Occlusion Cohort
Patients with CRVO undergoing OCT/OCTA imaging as part of routine care.
Other: No 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.
Age-related Macular Degeneration Cohort
Patients diagnosed with AMD and evaluated using OCT/OCTA.
Other: No 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.
Pathologic Myopia with Choroidal Neovascularization Cohort
Patients with pathologic myopia and CNV who undergo OCT/OCTA imaging.
Other: No 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.
Glaucoma Cohort
Patients with glaucoma-related optic nerve damage undergoing OCT/OCTA imaging.
Other: No 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the AI-assisted OCT/OCTA model (AUC for multi-disease classification)
Time Frame: Baseline imaging visit (time of image acquisition and model inference).
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.
Baseline imaging visit (time of image acquisition and model inference).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the AI-assisted OCT/OCTA model
Time Frame: At the time of image acquisition and model inference (baseline imaging visit).
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.
At the time of image acquisition and model inference (baseline imaging visit).
Agreement between AI-assisted diagnosis and clinician diagnosis
Time Frame: At the time of image acquisition and model inference (baseline imaging visit).
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.
At the time of image acquisition and model inference (baseline imaging visit).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K9164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) are not planned for public sharing at this time due to institutional policies and ethical restrictions on releasing identifiable clinical imaging data. De-identified aggregated results may be shared upon reasonable request and in compliance with applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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