RecruitingNot ApplicableNCT06289491

A Trial of Hydrus Microstent Versus Goniotomy

Randomized Trial of Hydrus Microstent Versus Goniotomy


Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

243 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical procedures for glaucoma — the Hydrus Microstent (a tiny device placed inside the eye's drainage channel) versus goniotomy (a procedure to open the drainage channel) — in patients who also need cataract surgery. **You may be eligible if...** - You have mild to moderate open-angle glaucoma, including pigmentary glaucoma or pseudoexfoliation glaucoma - You have a visually significant cataract that is already planned for surgery - Your eye pressure while on medication is between 10 and 31 mmHg - You are willing and able to attend follow-up appointments **You may NOT be eligible if...** - You have severe glaucoma with significant central vision loss - You have a type of glaucoma other than open-angle (e.g., closed-angle glaucoma) - You have had prior glaucoma surgery or other complicating eye conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHydrus Microstent

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

PROCEDUREIncisional goniotomy

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

PROCEDUREExcisional goniotomy

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


Locations(1)

Massachusetts Eye and Ear

Boston, Massachusetts, United States

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NCT06289491


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