Which glaucoma surgery works best with cataract removal?
NCT ID NCT06289491
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 243 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Massachusetts Eye and Ear
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Eye drops may shield the cornea after cataract surgery
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- Can a puff of air replace the eye pressure probe?