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New eye camera tested for glaucoma detection

NCT ID NCT06305481

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new imaging device called the P200TE on 53 people with glaucoma. The goal was simply to see how well it could capture images of the back of the eye. It was not a treatment study, so there were no health benefits or risks for participants.

What this could mean

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

Active substance
P200TE imaging device

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

53 people

The number who actually took part.

Started

Feb 2024

Finished

Oct 2024

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 * Subjects were 22 years of age or older on the date of informed consent; * Subjects were able to understand the written informed consent and willing to participate as evidenced by signing the informed consent; * BCVA 20/40 or better in the study eye; * History of visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings: On pattern deviation (PD), there existed a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or Glaucoma hemi-field test "outside normal limits;" -Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; and Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue. Exclusion Criteria * Subjects unable to tolerate ophthalmic imaging; * Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye; * 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; * No reliable visual field test result within the past year of the study visit, defined as fixation losses \> 33% or false positives \>33%, or false negatives \>33% in the study eye; * Presence of any ocular pathology except glaucoma in the study eye.

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Conditions

The condition(s) this trial relates to.

glaucoma

As listed by the trial registrant

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

Glaucoma

Contacts and locations

Locations

  • Specialty Eyecare Centre

    Bellevue, Washington, 98004, United States

  • Werner Optometry

    Cajon, California, 92019, United States

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