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Eye blood flow may reveal glaucoma before vision loss

NCT ID NCT05344274

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether measuring blood flow in the retina can help detect early glaucoma. Researchers will use special dyes and imaging to see how blood vessels respond to oxygen. The goal is to find a reliable early warning sign for the disease. About 90 adults with early glaucoma or healthy eyes will take part.

What this could mean

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

Active substance
Indocyanine green dye and oxygen supplementation
What this could lead to
If successful, this could lead to a simple, non-invasive test to detect glaucoma earlier, potentially preventing vision loss.
What could go wrong
This is a small, early-phase study focused on finding a biomarker, not a treatment. The results may not translate into a widely usable test.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

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

Started

May 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 88 years

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. age over 18 years 2. open angle in gonioscopy (grade 3 or 4 in Shaffer classification) 3. refractive error within the range of +3.00 to -8.00 diopters (4) best-corrected visual acuity 20/25 or better (5) Individuals recruited will be in one of the 3 groups: 1\) Early Glaucoma as per Hodapp-Anderson-Parrish Criteria (54). Early glaucoma subjects specifically with visual field defects restricted to one side of the horizontal midline will be selected to allow for comparison of rates of progression in both hemifields. Individuals will need to be off of glaucoma medications for four weeks to participate in the study. 2) Pre-perimetric glaucoma defined as the presence of glaucomatous optic nerve damage (e.g., focal notching, rim thinning), RNFL defect, and the absence of a definite glaucomatous visual field defect using standard automated perimetry at the three most recent consecutive examinations. A glaucomatous visual field defect is defined as either 3 or more abnormal points with a P\<0.05, of which at least 1 point has a pattern standard deviation (PSD) of P\<0.01; or a PSD of P\<0.05; or glaucoma hemifield test values outside the normal limits. (55,56) 3) Control group - A subject with no family history of glaucoma who has the following: a) OCT with all four quadrants within the normal range for age-matched controls, b) reliable visual fields with glaucoma hemifield test within normal limits and determined to be normal by a glaucoma specialist, and c) cup-to-disc ratio of 0.4 or lower and asymmetry of the cup to disc ratio no greater than 0.1 as determined by a glaucoma specialist. Control subjects will be age matched to the early glaucoma subjects. Exclusion Criteria: 1. corneal abnormalities or other conditions preventing reliable applanation tonometry 2. retinal disease affecting retinal nerve fiber layer thickness such as vitreomacular traction as determined by a glaucoma specialist 3. secondary glaucoma 4. history of prior ocular surgery other than uncomplicated cataract surgery or laser trabeculoplasty 5. inability to safely be off of glaucoma medications for 4 weeks 6. inability to obtain OCT angiography data due to excessive eye motion or inability to fixate 7. unreliable visual fields 8. any history of smoking in the past 6 months 9. cataract greater than lens opacity classification system (LOCS) II Grade≥2 10. diagnosis of diabetes, hypertension, or other known vascular disorder such as vasculitis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 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

  • Food and Drug Administration (FDA)

    RECRUITING

    Silver Spring, Maryland, 20903, United States

  • University of Maryland Faculty Physicians, Inc

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Maryland, Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

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