NCT07446582Recruiting
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- Feb 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- AI-Spectral
- Diseases
- Macular degeneration
- NCT number
- NCT07446582
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Feb 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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. -
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Contact Lens & Vision Coordinator of this site? Confirm its status | Woodbridge | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.