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The goal of this observational clinical study is to learn if DeepMSI AI detects age-related macular degeneration (AMD) biomarkers with sensitivity and specificity equivalent to experienced clinicians in adults over 40 years old. The main questions it aims to answer are:
Researchers will compare retina image analysis from DeepMSI AI with ground truth (clinicians' interpretations) to see if AI achieves equivalency in sensitivity and specificity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMD eyes | Eyes with Drusen and/or GA |
| |
| Healthy eyes | Subjects over 40 years of age have not been diagnosed with any type of AMD and prior imaging that shows no signs of AMD or other types of retinopathies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retina imaging device (MSI-120) and AI (DeepMSI AI) | Device | This is single-arm intervention where device use (acquiring retina images with MSI-120 device and analyzing retinal images with the DeepMSI AI) is the primary intervention to assess performance. To eliminate any potential risk to patients, AI outputs from this study will not be disclosed to treating clinicians or participants during the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers. | Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers (including drusen, GA) at the eye level as identified on MSI images, using the consensus of two masked retina experts as the reference standard. | through study completion, an average of 6 months |
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Inclusion Criteria: AMD subjects:
Healthy subjects:
Exclusion Criteria:
Assessed prior to any considerations of inclusion:
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The study will enroll participants across the planned study sites including primary eye care and eye clinics in the USA. The study will include adults aged 40 years and older who have been previously imaged with retinal imaging instruments, meet all protocol-specified inclusion and exclusion criteria, and provide informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela F. Esfandiarinezhad, PhD | Contact | 16135816702 | angela.f@deepmsi.com | |
| Emily Zhang, MD. PhD | Contact | EmilyZ@deepmsi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Lens & Vision | Recruiting | Woodbridge | New Jersey | 07095 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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