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Hydrus Microstent, Incisional Goniotomy, or Excisional Goniotomy for Glaucoma

This study is comparing three different surgical procedures for people with mild to moderate open-angle glaucoma who are also having cataract surgery. The procedures are: Hydrus Microstent insertion, incisional goniotomy (opening a part of the eye called the trabecular meshwork), and excisional goniotomy (removing part of the trabecular meshwork). The main goal is to see how well each procedure lowers eye pressure and how safe they are over three years. You might be able to join if you are between 40 and 85 years old, need cataract surgery, and have mild to moderate open-angle glaucoma. The study is planning to enroll 243 participants, but its current status is unclear.

Study design
This study will randomly assign participants to one of three surgical procedures in combination with cataract surgery. It plans to enroll 243 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your intraocular pressure and use of eye pressure-lowering medications will be measured for 3 years after the surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06289491

A Trial of Hydrus Microstent Versus Goniotomy

Recruiting
NAAges 40–85InterventionalTreatment
Massachusetts Eye and Ear Infirmary
~243 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Hydrus MicrostentIncisional goniotomyExcisional goniotomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intraocular pressure
Measured over 3 years
+1 more outcome measured

Conditions

Glaucoma
Glaucoma, Open-Angle

Explore related trials

Open Angle Glaucoma

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Michael M Lin, MD
[email protected]
617-573-3707
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Intraocular pressure3 years
  • Intraocular pressure-lowering medications3 years