A Trial of Hydrus Microstent Versus Goniotomy

NCT ID: NCT06289491

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2029-04-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrus Microstent

Group Type: EXPERIMENTAL

Hydrus Microstent

Intervention Type: PROCEDURE

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

Incisional goniotomy

Group Type: EXPERIMENTAL

Incisional goniotomy

Intervention Type: PROCEDURE

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

Excisional goniotomy

Group Type: EXPERIMENTAL

Excisional goniotomy

Intervention Type: PROCEDURE

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

Interventions

Hydrus Microstent

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

Intervention Type: PROCEDURE

Incisional goniotomy

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

Intervention Type: PROCEDURE

Excisional goniotomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Michael M. Lin, MD

Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael M Lin, MD

Role: CONTACT

michael_lin@meei.harvard.edu

617-936-6082

Facility Contacts

Michael Lin, MD

Role: primary

michael_lin@meei.harvard.edu

617-936-6082

Other Identifiers

2024P000544

Identifier Type: -

Identifier Source: org_study_id