Actively Recruiting
A Trial of Hydrus Microstent Versus Goniotomy
Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-03-30
243
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial of Hydrus Microstent Versus Goniotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Visually significant cataract planned for surgery
- Mild to moderate open-angle glaucoma, including pigmentary and pseudoexfoliation glaucoma
- Mild glaucoma with optic nerve damage and visual field mean deviation better than -6.0 dB
- Moderate glaucoma with mean deviation between -6.0 dB and -12.0 dB without central vision loss
- Medicated intraocular pressure between 10 to 31 mm Hg at surgery decision
- Able and willing to provide informed consent
- Able and willing to attend all postoperative visits per protocol
You will not qualify if you...
- Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
- Selective laser trabeculoplasty within 90 days before enrollment
- Iridotrabecular contact over 180 degrees or more
- Peripheral anterior synechiae in nasal or inferior angle
- Best corrected visual acuity worse than 20/200
- Phacodonesis or vitreous in anterior chamber before surgery
- Nanophthalmos
- Use of anti-platelet or anticoagulant medications other than aspirin 81mg daily
- Active treatment for other eye conditions in either eye
- Abnormality in study eye affecting tonometry
- Glaucoma types other than mild or moderate open-angle
- Normal tension glaucoma
- Conditions causing elevated episcleral venous pressure
- History of uveitis in either eye
- Unable to complete gonioscopy examination
- Oral steroid use within 90 days or planned use
- Use of oral medications affecting intraocular pressure
- History of steroid-induced intraocular pressure elevation
- Medically unfit for study visits
- Participation in another interventional research study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Michael M Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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