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

Conditions

• Age-Related (Dry) Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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 Dates

Start date

Feb 1, 2026

Status verified

Mar 2026

Primary completion

Sep 5, 2026

Completion

Sep 5, 2026

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: AMD eyes
  Eyes with Drusen and/or GA
• Arm: 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.

Primary Outcome Measure

Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers. [ Time Frame: through study completion, an average of 6 months ]

Central Contacts

• Angela F. Esfandiarinezhad, PhD
  16135816702
  [email protected]
• Emily Zhang, MD. PhD
  [email protected]

Locations (1)

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