Hydrus Microstent vs Goniotomy for Glaucoma

Overseen By Michael M Lin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Anticoagulants, Oral steroids

Disqualifiers: Prior glaucoma surgery, Other glaucoma, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

243 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients with mild to moderate open-angle glaucoma who also need cataract surgery. They should have a certain level of visual field mean deviation and intraocular pressure (IOP) between 10 to 31 mm Hg. Participants must understand the study and commit to follow-up exams.

Inclusion Criteria

I am scheduled for cataract surgery due to vision problems.

I can attend all follow-up visits after surgery as required.

Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery

Exclusion Criteria

I am not on blood thinners except for low-dose aspirin.

I have been diagnosed with normal tension glaucoma.

I am not taking oral medications that can affect eye pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three microinvasive glaucoma surgeries (Hydrus Microstent, incisional goniotomy, or excisional goniotomy) in combination with cataract surgery

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

12 months

Treatment Details

Interventions

• Excisional goniotomy
• Hydrus Microstent
• Incisional goniotomy

Trial Overview The trial compares three microinvasive glaucoma surgeries: Hydrus Microstent, incisional goniotomy, and excisional goniotomy, each combined with cataract surgery. It aims to see which one better lowers eye pressure and has fewer risks.

Participant Groups

Group I: Incisional goniotomy Experimental Treatment 1 Intervention

Group II: Hydrus Microstent Experimental Treatment 1 Intervention

Group III: Excisional goniotomy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+