High-throughput Large-model-based AI-assisted Diagnosis Using OCT (NCT07249307) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High-throughput Large-model-based AI-assisted Diagnosis Using OCT
2,000 participantsStarted 2025-11-30
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic performance of the AI-assisted OCT/OCTA model (AUC for multi-disease classification)
Timeframe: Baseline imaging visit (time of image acquisition and model inference).