A Trial of Hydrus Microstent Versus Goniotomy

Randomized Trial of Hydrus Microstent Versus Goniotomy

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Glaucoma, Open-Angle
• Intervention / Treatment: Procedure: Hydrus Microstent; Procedure: Incisional goniotomy; Procedure: Excisional goniotomy

• Study Type: Interventional
• Enrollment (Estimated): 243
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael M Lin, MD; Phone Number: 617-573-3707; Email: michael_lin@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts Eye and Ear
      • Principal Investigator: Michael Lin, MD
      • Contact: Michael Lin, MD; Phone Number: 617-573-3707; Email: michael_lin@meei.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrus Microstent	Procedure: Hydrus Microstent; Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery
Experimental: Incisional goniotomy	Procedure: Incisional goniotomy; Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery
Experimental: Excisional goniotomy	Procedure: Excisional goniotomy; Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular pressure	3 years
Intraocular pressure-lowering medications	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical complications	3 years

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Goniotomy; Incisional goniotomy; Excisional goniotomy; Hydrus Microstent
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2024P000544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes