AI eye scanner could catch dry AMD early in 1,000-Person trial
NCT ID NCT07446582
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether an AI system called DeepMSI AI can detect biomarkers of dry age-related macular degeneration (AMD) as accurately as experienced eye doctors. About 1,000 adults over 40, including those with and without AMD, will have their retinas imaged with a special camera. The AI's analysis will be compared to the judgment of retina specialists to see if the technology is reliable enough for future use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Retina imaging device (MSI-120) and AI software (DeepMSI AI)
- What this could lead to
- If successful, this could provide a fast, AI-powered way to detect early signs of dry age-related macular degeneration, potentially improving diagnosis and monitoring.
- What could go wrong
- This is an early-stage study focused on accuracy, not treatment. The AI results are not shared with doctors during the trial, so there is no direct benefit to participants. The technology may not prove equivalent to human experts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will enroll participants across the planned study sites including primary eye care and eye clinics in the USA. The study will include adults aged 40 years and older who have been previously imaged with retinal imaging instruments, meet all protocol-specified inclusion and exclusion criteria, and provide informed consent.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: AMD subjects: 1. Subjects over 40 years of age diagnosed for ne AMD 2. Subject must be able to understand and must sign an IRB-approved ICF 3. Subject must have minimum of one prior visit to the clinic 4. 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: 1. 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. 2. A minimum of light perception visual acuity is required to detect the fixation target during imaging. 3. Two masked clinicians must confirm and categorize them into healthy eyes. - Exclusion Criteria: * Assessed prior to any considerations of inclusion: 1. Eyes with significant refractive media opacity (e.g. corneal opacity, significant cataract) that prevents adequate imaging 2. Severe Refractive Error: Extreme high myopia (≥ -10.00D) or hyperopia (≥ +6.00D) that may compromise image quality. 3. Unstable Ocular Conditions: Active ocular infections, severe uveitis, or status-post ocular trauma 4. 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). 5. 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. 6. 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. 7. Inability to Maintain Fixation: Including patients with advanced nystagmus, severe amblyopia, or cognitive impairments (dementia) affecting fixation stability. 8. Severe Dry Eye or Ocular Surface Disease: Conditions that may interfere with imaging quality or patient comfort during the procedure. 9. Subjects with essential tremor (head and neck tremors or unstable fixation to prevent adequate imaging) 10. Inability to understand and refusal to sign informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Contact Lens & Vision
RECRUITINGWoodbridge, New Jersey, 07095, United States
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