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Can a new eye scanner set the standard for healthy vision?

NCT ID NCT05844852

Knowledge-focused Sponsor: Optos, PLC 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

Researchers are collecting detailed eye images from about 954 healthy adults aged 22 and older to build a reference database for the Optos P200TE, an eye imaging device. The study measures retinal thickness, nerve fiber layer, and optic nerve head dimensions using OCT scans. The goal is to establish normal values that could help doctors interpret scans and spot abnormalities in the future. Participants must have normal eyes, though common conditions like cataracts or prior LASIK are allowed.

What this could mean

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

Active substance
Optos P200TE imaging device
What this could lead to
If successful, this could provide a standard reference for interpreting eye scans, helping doctors better detect and monitor eye conditions.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. The reference data may not apply to all populations or eye 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

954 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2023

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

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.

Inclusion Criteria: 1. Subjects 22 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed. 4. BCVA (best corrected visual acuity) 20/40 or better(each eye) 5. Subject is able to comply with the study procedures Exclusion Criteria: 1. Subjects unable to tolerate ophthalmic imaging 2. Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study 3. Subject with ocular media not sufficiently clear toobtain acceptable OCT images 4. .History of leukemia, dementia or multiple sclerosis

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As listed by the trial registrant

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

Normal eyes

Contacts and locations

Locations

  • Center for Sight

    Venice, Florida, 34292, United States

  • Eyecare of San Diego

    San Diego, California, 92103, United States

  • Illinois College of Optometry

    Chicago, Illinois, 60616, United States

  • Marshall B Ketchum University, Southern California College of Optometry

    Anaheim, California, 92807, United States

  • New England College of Optometry

    Boston, Massachusetts, 02215, United States

  • New England College of Optometry

    Roslindale, Massachusetts, 02131, United States

  • Specialty Eye Care Centre

    Bellevue, Washington, 98004, United States

  • State University of New York, Clinical Vision Research

    New York, New York, 10036, United States

  • Werner Optometry

    San Diego, California, 92019, United States

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