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A Trial of Hydrus Microstent Versus Goniotomy

NCT06289491 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-03-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2027-04-30
Completion
2029-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289491 on ClinicalTrials.gov