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Which eye implant best tames glaucoma? a head-to-head trial aims to find out.

NCT ID NCT07733453

Disease control Sponsor: University of Sydney 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This trial compares two surgical implants—the Baerveldt Glaucoma Implant and the Paul Glaucoma Implant—in people with glaucoma that is not well controlled by eye drops. Both devices are tiny tubes placed in the eye to drain fluid and lower pressure. The study will track which implant works better over the long term and whether one has fewer complications.

What this could mean

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

Active substance
a surgical implant (Baerveldt or Paul glaucoma implant) that drains fluid from the eye to lower pressure
What this could lead to
If one implant proves safer or more effective, it could become the preferred option for people with hard-to-control glaucoma.
What could go wrong
This is a single trial with 150 participants, so results may not apply to everyone. Both implants carry surgical risks like infection or implant failure.

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 150 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2033

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 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. Age ≥ 18 years of age 2. Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 16 mm Hg. 3. An aqueous shunt implant as planned surgical procedure 4. A diagnosis of ocular hypertension, primary open angle glaucoma, primary angle closure glaucoma, or secondary glaucoma. Exclusion Criteria: 1. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits. 2. Pregnant or nursing women. 3. No light perception vision. 4. Uveitis secondary to Juvenile Idiopathic Arthritis 5. Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye 6. Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation 7. Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation 8. Vitreous present in the anterior chamber, sufficient to require a vitrectomy at the time of surgery 9. Condition with high episcleral pressure, such as Sturge-Weber or nanophthalmos 10. Acute trauma (within 3 months) 11. Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.

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Conditions

The condition(s) this trial relates to.

glaucoma ocular hypertension open-angle glaucoma primary angle-closure glaucoma

As listed by the trial registrant

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

Glaucoma

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

    4 sites. 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

Locations

  • Liverpool Hospital

    Sydney, New South Wales, 2170, Australia

  • Royal Victorian Eye and Ear Hospital

    Melbourne, Victoria, 3000, Australia

    Contact Email: •••••@•••••

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Westmead Hospital

    Sydney, New South Wales, 2145, Australia

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