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AI eye scanner could catch dry AMD early in 1,000-Person trial

NCT ID NCT07446582

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Contact Lens & Vision

    RECRUITING

    Woodbridge, New Jersey, 07095, United States

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Other studies related to the condition(s) this trial covers.