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Can a new eye scanner match the gold standard?

NCT ID NCT07768735

Knowledge-focused Sponsor: Alcon Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study evaluates whether an investigational eye imaging device, UNITY DX, can measure the thickness of the cornea and its epithelial layer as accurately and consistently as a commercially available device. About 110 participants with normal or abnormal corneas will undergo multiple eye measurements. The goal is to assess agreement, repeatability, and reproducibility of the thickness maps produced by the device.

What this could mean

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

Active substance
Investigational non-contact, non-invasive ophthalmic imaging device (UNITY DX)
What this could lead to
If successful, this could validate a new tool for precise eye measurements, potentially improving diagnosis and monitoring of corneal conditions.
What could go wrong
This is a validation study, not a treatment trial. The new device may not match the accuracy of the existing one, and results may not apply to all patients.

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 110 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

Cohorts will be selected from approximately one investigative site located in the United States.

Ages

22 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.

Key Inclusion Criteria: * Able to understand and sign an Institutional Review Board approved informed consent form. * Willing and able to attend all scheduled study visits as required per protocol. * Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus. * Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study. * Active ocular infection or inflammation. * Other protocol-specified exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome keratoconus

As listed by the trial registrant

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

Tomography

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

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107, United States

More trials for these conditions

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