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Can new OCT scanners see eye disease better?

NCT ID NCT07338461

Knowledge-focused Sponsor: Heidelberg Engineering GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This pilot study will test two new eye imaging devices (R1 and HighRes OCT) against a standard device in 97 adults with healthy eyes or eye diseases like macular degeneration and diabetic retinopathy. Researchers will compare image quality and how well key eye structures are seen. The goal is to see if the new devices provide clearer, more useful images for diagnosis.

What this could mean

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

What this could lead to
If successful, this study could lead to better imaging tools for diagnosing and monitoring eye diseases like macular degeneration and diabetic retinopathy.
What could go wrong
This is a small pilot study focused on image quality, not treatment. The new devices may not show clear improvement over existing technology.

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 97 people

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

Started

Mar 2026

Expected to finish

Mar 2027

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: * All Able and willing to undergo the test procedures, give consent, and to follow instructions. Signed informed consent Age ≥ 18 years * Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20/40 No reported history of ocular surgical intervention (except for refractive or cataract surgery) * Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular * Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator * Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator Exclusion Criteria: * Subjects unable to read or write * Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging * Subjects who cannot tolerate the imaging procedures * History of photosensitive epilepsy * Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration diabetic retinopathy macular degeneration retinal disorder

As listed by the trial registrant

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

Age-related macular degeneration Diabetic retinopathy Eyes with retinal diseases Normal eyes

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

  • Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan

    RECRUITING

    Milan, 20157, Italy

More trials for these conditions

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