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We developed an artificial intelligence system, called QiLin, which was designed to assist anti-VEGF treatment decisions in retinal diseases. QiLin was trained and validated via over 20,000 optical coherence tomography images from multicenter datasets, demonstrating strong performance on both internal and external validation. To evaluate its real-world clinical utility, we conducted a randomized controlled trial that rigorously compares the accuracy of treatment decisions between a physician-only arm and an AI-assisted physician arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QiLin-assisted physician arm | Experimental |
| |
| physician only arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QiLin-assisted | Other | A Comprehensive Deep Learning Model for Assisting the decision of anti-VEGF therapy: QiLin system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the current anti-VEGF injection decision | The accuracy of the current anti-VEGF injection decision was defined as the proportion of injection decisions (yes or no) made by the physicians in the two arms that were in agreement with the independent senior expert. | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of detecting active biomarkers on the current OCT image | The secondary endpoint was defined as the accuracy of detecting active biomarkers. For each patient, the physician was required to perform a binary classification (present vs. absent) for all of 8 pre-defined active biomarkers (PED, NV, IRF, SRF, SHRM, HRF, DRT or DME, and VMT), and was further confirmed by an independent senior retina specialist. The accuracy for per biomarker was calculated as the proportion of correct classifications for that biomarker, and then the average accuracy was calculated as the secondary endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the recommended anti-VEGF treatment interval | At enrollment, physicians in both arms will recommend an anti-VEGF treatment interval. Then, patients will attend monthly visits for 3 months. At each visit, an independent expert physician will evaluate whether anti-VEGF injection is required. The accuracy of the recommended treatment interval is defined as the proportion of cases where the recommended treatment interval is concordant with the actual treatment interval. |
Inclusion Criteria:
Patients with a diagnosis of nAMD, DME, and RVO; Patients who have completed the loading-dose treatment of anti-VEGF agents; Patients who were willing to participate and provided written informed consent.
Exclusion Criteria:
Refusal to undergo OCT testing; Refusal to complete the 3-month follow-up period; Screening for a history of intraocular surgery within the past 6 months; Subjects with severe systemic diseases, intellectual developmental disorders, psychiatric illnesses, etc.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Prof. Sun, PhD | Contact | 86 17853138155 | xdsun@sjtu.edu.cn | |
| Huixun Jia, PhD | Contact | 86 17853138155 | jiahuixun@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaodong Sun, PhD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai general hospital, Shanghai Jiao Tong University, Shanghai, 200080 | Shanghai | China |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| physician only, without QiLin assisted | Other | without QiLin assisted |
|
| At enrollment |
| 3 months from enrollment |
| Shanghai general hospital | Shanghai | China |
|
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012162 | Retinal Degeneration |