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Which glaucoma surgery works best with cataract removal?

NCT ID NCT06289491

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares three types of glaucoma surgery (Hydrus Microstent, incisional goniotomy, and excisional goniotomy) done at the same time as cataract surgery. About 243 adults with mild to moderate open-angle glaucoma will take part. The goal is to see which surgery lowers eye pressure best and has the fewest side effects.

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 243 people

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

Started

Feb 2025

Expected to finish

Apr 2029

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

40 to 85 years

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: * Visually significant cataract planned for surgery * Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma * Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees \<15 dB * Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points \<15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point \<15 dB * Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery * Willing and able to understand and provide informed consent * Willing and able to attend postoperative examinations per protocol schedule Exclusion Criteria: * Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation * Selective laser trabeculoplasty within 90 days of study enrollment * Iridotrabecular contact for 180 degrees or greater * Peripheral anterior synechiae in nasal or inferior angle * Best corrected visual acuity worse than 20/200 * Phacodonesis on pre-operative examination * Vitreous in anterior chamber on pre-operative examination * Nanophthalmos * Anti-platelet and anticoagulant medications other than aspirin 81mg daily * Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant) * Abnormality in study eye that could affect tonometry * Glaucoma diagnosis other than the above * Normal tension glaucoma * Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor) * History of uveitis in either eye * Inability to complete gonioscopy examination * Use of oral steroids within 90 days or anticipated use of oral steroids * Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide * History of steroid-associated IOP elevation * Medically unfit for attending planned study visits * Involvement in another interventional research 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 places running it

    1 site. 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

  • Massachusetts Eye and Ear

    RECRUITING

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.