Recruiting

Hydrus Microstent vs. Goniotomy

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06289491

Conditions

Glaucoma

Glaucoma, Open-Angle

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Hydrus Microstent

Incisional goniotomy

Excisional goniotomy

Study Details

Brief summary:

The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:

  • How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
  • How do the safety profiles of these three microinvasive glaucoma surgeries compare?

Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.

Conditions

Glaucoma

Glaucoma, Open-Angle

Study ID

NCT06289491

Start date

Feb 14, 2025

Status verified date

Mar, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

243 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydrus Microstent

experimental: Incisional goniotomy

experimental: Excisional goniotomy

Interventions

Hydrus Microstent

Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery

Incisional goniotomy

Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery

Excisional goniotomy

Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery

Primary outcome measure

  • Intraocular pressure [ Time Frame: 3 years ]
  • Intraocular pressure-lowering medications [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Michael M Lin, MD

617-573-3707michael_lin@meei.harvard.edu

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Lin, MD

617-573-3707michael_lin@meei.harvard.edu

Principal Investigator:

Michael Lin, MD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Incisional goniotomy
  • Excisional goniotomy
  • Hydrus Microstent
  • Goniotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-03-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.