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Can a tiny eye implant replace glaucoma drops?

NCT ID NCT07754201

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This trial tests a new device called VividFlo, a small implant placed under the eye's surface to help drain fluid and lower pressure in people with glaucoma. The study involves 10 adults with glaucoma in one eye, who will receive the implant during surgery. Researchers will track eye pressure, the need for pressure-lowering medications, and any safety issues over 12 months. The goal is to see if this implant can safely and effectively control eye pressure and potentially reduce the need for daily eye drops.

What this could mean

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

Active substance
VividFlo System (a subconjunctival glaucoma implant placed in the eye using a partial-thickness scleral flap technique)
What this could lead to
If successful, this could offer a new surgical option for glaucoma patients to lower eye pressure and reduce reliance on daily eye drops.
What could go wrong
This is a very small early study (10 people) focused on safety and feasibility. The implant may not lower pressure enough, or could cause complications like erosion or vision changes.

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 10 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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

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: 1. Age, Capacity \& Consent: 1. Be 18 years of age or older. 2. Be able to understand all study instructions, and willing to comply with all study procedures and the visit schedule. 3. Provide written, informed consent to participate. 2. Glaucoma in the study eye, meeting all of the following requirements: 1. Diagnosed by the investigator, based upon untreated intraocular pressure, disc appearance and visual field abnormalities. 2. The glaucoma type is one of: i. Primary open angle glaucoma (POAG). ii. Chronic angle closure glaucoma (CACG) where the eye is pseudophakic. iii. Mixed mechanism POAG/CACG where a laser iridotomy has previously been performed. iv. Pigmentary open angle glaucoma. v. Exfoliation open angle glaucoma. vi. Neovascular glaucoma that is treated and regressed/quiescent. c. Glaucoma drainage surgery is indicated due to failure of previous treatment (the glaucoma is 'refractory'), with failure of maximum tolerated medical therapy and one of the following circumstances: i. No previous glaucoma surgery. ii. Prior trabecular bypass (using iStents or Hydrus) or cilioablation. iii. Failure of one prior glaucoma drainage operation (that is one of trabeculectomy, deep sclerectomy or Xen). d. The mean diurnal IOP at Baseline is greater than or equal to 20 mmHg and less than or equal to 40 mmHg. e. The conjunctiva in the target quadrant is suitable for glaucoma surgery. Key Exclusion Criteria: * Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator. * The glaucoma type is any of the following: 1. Acute Angle Closure Glaucoma (AACG). 2. Chronic Angle Closure Glaucoma (CACG) where the eye is phakic. 3. Congenital glaucoma. Juvenile Open-Angle Glaucoma or Congenital Glaucoma. 4. Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma. * Previous glaucoma surgery with: 1. A tube-and-plate glaucoma drainage implant (GDI, e.g. Molteno, Baerveldt, Paul). 2. A suprachoroidal implant. 3. Multiple previous operations for glaucoma. 4. Glaucoma surgery within 3 months of screening. * Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration. * Conjunctival scarring or pterygium in the target quadrant. * Severe dry eye disease. * Significant corneal disease. * Accurate measurement of baseline central corneal endothelial density is not possible. * Any treatment or condition that, in the opinion of the investigator, may impact corneal endothelial cell density beyond expected age \& disease-related decline. * Significant retinal or posterior segment pathology, including but not limited to: 1. Active and clinically significant diabetic retinopathy. 2. Active choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy. 3. Intraocular silicone oil. 4. Presence of a scleral buckle. * Vitreous present in the anterior chamber. * Active uveitis or clinically significant infection or inflammation. * Unfit for surgery under local anaesthetic. * Any uncontrolled systemic disease. * The participant is pregnant, breastfeeding, or cannot guarantee they will not conceive or donate sperm or eggs during the study. * Significant risk of bleeding. * Any other clinical or social reason that, in the opinion of the investigator, means standard surgical treatment for glaucoma would be considered safer than participation in the study.

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Melbourne Eye Specialists

    Fitzroy, Victoria, 3065, Australia

    Contact Email: •••••@•••••

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