NCT06289491

A Trial of Hydrus Microstent Versus Goniotomy

Randomized Trial of Hydrus Microstent Versus Goniotomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Hydrus Microstent	Patients will have a Hydrus Microstent inserted into the canal of Schlemm at the time of cataract surgery
PROCEDURE	Incisional goniotomy	Patients will have incisional goniotomy to open the trabecular meshwork with a Sinskey hook at the time of cataract surgery
PROCEDURE	Excisional goniotomy	Patients will have excisional goniotomy to remove the trabecular meshwork with a Kahook Dual Blade at the time of cataract surgery

Timeline

• Start date: 2025-02-14
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2024-03-04
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study