Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

Recruiting now

Conditions studied: Age-Related (Dry) Macular Degeneration

In brief

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.

Key facts

Study ID

NCT07446582

Run by

AI-Spectral

People needed

1000

Starts

2026-02-01

Expected to finish

2026-09-05

Last updated by the study team

2026-03-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Assessed prior to any considerations of inclusion:
• Eyes with significant refractive media opacity (e.g. corneal opacity, significant cataract) that prevents adequate imaging
• Severe Refractive Error: Extreme high myopia (≥ -10.00D) or hyperopia (≥ +6.00D) that may compromise image quality.
• Unstable Ocular Conditions: Active ocular infections, severe uveitis, or status-post ocular trauma
• Recent Intraocular Surgery: Patients who have undergone intraocular surgery (e.g., cataract, retinal, or glaucoma surgery) within the past 3 months (except for intravitreal injections for GA therapy).
• History or Current Evidence of other types of retinopathy other than neAMD, e.g. Acute Retinal artery or Vein Occlusion, Diabetic Retinopathy, Idiopathic Epiretinal membrane, Myopic Maculopathy, Hypertension Retinopathy etc.
• History of Vitrectomy or Scleral Buckling for any kind of Vitreoretinopathy, e.g. Retinal Detachment, Epiretinal Membrane, Proliferative Diabetic Retinopathy etc. that could distort imaging results.
• Inability to Maintain Fixation: Including patients with advanced nystagmus, severe amblyopia, or cognitive impairments (dementia) affecting fixation stability.
• Severe Dry Eye or Ocular Surface Disease: Conditions that may interfere with imaging quality or patient comfort during the procedure.
• Subjects with essential tremor (head and neck tremors or unstable fixation to prevent adequate imaging)
• Inability to understand and refusal to sign informed consent

Where it is running

• Contact Lens & Vision — Woodbridge, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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