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AI eye scanner could catch retina disease earlier

NCT ID NCT07680244

Diagnosis Sponsor: Carl Zeiss Meditec-Dublin CoCe Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study evaluates PathFinder 1.0, a software that analyzes OCT images of the retina to detect macular abnormalities such as epiretinal membrane, dry age-related macular degeneration, and other retinal conditions. About 400 adults with and without macular issues will undergo standard OCT imaging, and the software's ability to correctly identify abnormalities will be measured. The goal is to see if this tool can reliably assist doctors in diagnosing retinal diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PathFinder 1.0 software on CIRRUS HD-OCT
What this could lead to
If successful, this software could help eye doctors spot macular abnormalities more accurately and quickly from routine OCT scans.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The software may not perform equally well across all types of retinal conditions.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

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

Started

May 2025

Expected to finish

Aug 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.

Ages

18 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: 1. Able and willing to make the required study visits. 2. Able and willing to give written informed consent and follow study instructions. 3. Able and willing to complete ophthalmic imaging. 4. Adults 18 years of age or older. The subject population will be comprised of two groups (all categories below pertain to the central 6x6 mm macula area): Group A 1\. Subjects with absence of macular abnormalities Group B 1. Subjects with Disruption of the vitreoretinal interface (VRI) 2. Subjects with Intraretinal hyporeflective space (IRHS) 3. Subjects with Subretinal hyporeflective space (SRHS) 4. Subjects with IS/OS (Ellipsoid Zone) disruption 5. Subjects with Retinal Pigment Epithelium (RPE) elevation 6. Subjects with Retinal Pigment Epithelium (RPE) atrophy 7. Other abnormalities Exclusion Criteria: 1. Inability to undergo the required tests. 2. Unable to give consent or follow study instructions. 3. Inability to fixate that precludes obtaining acceptable macula scans in the study eye. 4. Visudyne (verteporfin) injection within the last 48 hours in the study eye. 5. Pilocarpine or Vuity use within the last 24 hours in the study eye. 6. Dense media opacity precluding adequate visualization of the retina in the study eye. 7. Vitreous floaters that preclude obtaining acceptable scans in the study eye.

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Conditions

The condition(s) this trial relates to.

Atrophy dry age related macular degeneration preretinal fibrosis retinal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry age-related macular degeneration Epiretinal membrane Intraretinal hyporeflective space Is/os (ellipsoid zone) disruption Macular abnormalities Retina disease Retinal pigment epithelium (RPE) atrophy Retinal pigment epithelium (RPE) elevation Subretinal hyporeflective space Vitreoretinal abnormality

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. 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

  • Eyecare Medical Group

    RECRUITING

    Portland, Maine, 04102, United States

  • Moyes Eye Center

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • Northern California Retina Vitreous Associates

    RECRUITING

    Mountain View, California, 94040, United States

  • Nova Southeastern University College of Optometry

    RECRUITING

    Fort Lauderdale, Florida, 33328, United States

  • Premier Eyecare of San Francisco

    COMPLETED

    San Francisco, California, 94110, United States

  • Retina Associates

    RECRUITING

    Tucson, Arizona, 85704, United States

More trials for these conditions

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