Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dong-A University Hospital | OTHER |
| Kosin University Gospel Hospital | OTHER |
| Pusan National University Hospital | OTHER |
| Pusan National University Yangsan Hospital |
Not provided
Not provided
Not provided
Not provided
The purpose of this multi-center study is to evaluate the extent to which AI-assisted fundus image interpretation improves the diagnostic performance of ophthalmologists. Rather than assessing the standalone algorithm performance, this study aims to determine the clinical value of using AI as a decision-support tool within actual clinical workflows.
At each participating institution, five ophthalmologists within three years of board certification and five ophthalmology residents will participate as readers. All readers will interpret fundus images both with and without the AI-based assistance software. The study will quantitatively compare diagnostic accuracy and reading time across the two conditions for four posterior segment diseases: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Assisted Reading | Experimental | Readers interpret the fundus images with AI-generated outputs available. |
|
| Unassisted Reading | No Intervention | Readers interpret fundus images without access to the AI system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VUNO Med-Fundus AI | Device | The intervention consists of an AI-based fundus image interpretation software that provides automated outputs for 12 retinal and optic nerve findings (e.g., hemorrhage, exudates, drusen, optic disc change). The system does not generate a direct disease diagnosis. Instead, the AI displays the presence or absence of 12 predefined findings along with their lesion locations. Readers may use this finding-level information as decision-support when determining the presence of the four target diseases (diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, and glaucoma). |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of readers with and without AI assistance: Sensitivity | Sensitivity of reader diagnoses for each of the four target diseases (DR, AMD, RVO, glaucoma) and for any fundus abnormality will be assessed with and without AI assistance, using the image-level reference standard as the comparator, through two reading sessions in which all 10 readers review all cases-randomised for each reader-with a washout period implemented to mitigate recall bias. | Through study completion, approximately 2 months |
| Performance of readers with and without AI assistance: Specificity | Specificity of reader diagnoses for each of the four target diseases (DR, AMD, RVO, glaucoma) and for any fundus abnormality will be assessed with and without AI assistance, using the image-level reference standard as the comparator, through two reading sessions in which all 10 readers review all cases-randomised for each reader-with a washout period implemented to mitigate recall bias. | Through study completion, approximately 2 months |
| Reading time per image | Reading time per image will be measured during both unassisted and AI-assisted interpretation sessions. For each case, the total time from the moment the image is displayed to the moment the reader submits the final disease classification will be recorded automatically by the reading platform. Mean reading time per image will be calculated for each reader and compared between the two conditions to evaluate whether AI assistance reduces interpretation time. | Through study completion, approximately 2 months |
Not provided
Not provided
Ten readers will be recruited from five participating hospital sites, consisting of:
Ophthalmologists and residents of any age, sex, race, or ethnicity may participate as study readers. All readers must meet the following inclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea | |||
| Dong-A University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Busan |
| 49201 |
| South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012162 | Retinal Degeneration |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |