Actively Recruiting
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
Led by AI-Spectral · Updated on 2026-03-11
1000
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 40 years of age or older
- For AMD subjects: diagnosed with non-exudative AMD and have at least one prior clinic visit
- Prior imaging must show signs of non-exudative AMD in at least one eye (e.g., drusen, pigmentary changes, retinal atrophy)
- For healthy subjects: no diagnosis of AMD or other retinopathies and prior imaging confirming no signs of these conditions
- Healthy subjects must have at least light perception visual acuity to detect fixation during imaging
- Two masked clinicians must confirm and categorize healthy eyes
- Ability to understand and sign an IRB-approved informed consent form
You will not qualify if you...
- Eyes with significant opacity preventing clear imaging (e.g., corneal opacity, severe cataract)
- Extreme high myopia (≤ -10.00D) or hyperopia (≥ +6.00D) that may affect image quality
- Active ocular infections, severe uveitis, or recent ocular trauma
- Intraocular surgery within past 3 months (except intravitreal injections for GA therapy)
- History or current evidence of other retinopathies besides non-exudative AMD (e.g., diabetic retinopathy, retinal vein occlusion)
- History of vitrectomy or scleral buckling for vitreoretinopathy that may distort imaging
- Inability to maintain fixation due to conditions like advanced nystagmus, severe amblyopia, or cognitive impairment
- Severe dry eye or ocular surface disease interfering with imaging
- Essential tremor or unstable fixation preventing adequate imaging
- Inability or refusal to understand and sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Contact Lens & Vision
Woodbridge, New Jersey, United States, 07095
Actively Recruiting
Research Team
A
Angela F. Esfandiarinezhad, PhD
CONTACT
E
Emily Zhang, MD. PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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