Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) at Point-of-Care to Identify and Quantify Biomarkers of Non-Exudative Age-Related Macular Degeneration
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: * Does DeepMSI AI detect AMD biomarkers with sensitivity equivalent to experienced clinicians? * Does DeepMSI AI detect AMD biomarkers with specificity equivalent to experienced clinicians? Participants' eyes will be imaged by MSI-120 and their images will be analyzed for AMD biomarkers by both DeepMSI AI and retina specialists independently. Researchers will compare retina image analysis from DeepMSI AI with ground truth (clinicians' interpretations) to see if AI achieves equivalency in sensitivity and specificity.
• Subjects over 40 years of age diagnosed for ne AMD
• Subject must be able to understand and must sign an IRB-approved ICF
• Subject must have minimum of one prior visit to the clinic
• Prior imaging must show signs of neAMD (e.g. drusen of different sizes and types with macular pigmentary changes, complete or incomplete retinal pigment epithelium and outer retinal atrophy) at least in one eye
⁃ Healthy subjects:
• 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.
• A minimum of light perception visual acuity is required to detect the fixation target during imaging.
• Two masked clinicians must confirm and categorize them into healthy eyes. -