Actively Recruiting
Randomized Trial of Hydrus Microstent Versus Incisional and Excisional Goniotomy Combined With Cataract Surgery for Open-Angle Glaucoma
Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-03-30
243
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the effects of three microinvasive glaucoma surgeries combined with cataract surgery in patients with mild to moderate open-angle glaucoma. The study aims to compare how well the Hydrus Microstent, incisional goniotomy, and excisional goniotomy lower eye pressure and their safety profiles. Participants will be randomly assigned to one of these three surgical options during cataract surgery to evaluate their outcomes. Participants will receive one of three procedures during cataract surgery: insertion of the Hydrus Microstent into the canal of Schlemm, incisional goniotomy using a Sinskey hook to open the trabecular meshwork, or excisional goniotomy using a Kahook Dual Blade to remove part of the trabecular meshwork. These procedures are all done at the time of cataract surgery, and the study compares these different approaches to glaucoma surgery. During the study, participants will be monitored for up to three years. Researchers will measure intraocular pressure and the use of pressure-lowering medications over this time. They will also track any surgical complications. Participants must be able to attend all postoperative visits as scheduled to allow follow-up assessments. The study ensures thorough monitoring of both the effectiveness and safety of each surgical method over the long term.
CONDITIONS
Brief 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 glaucoma and pseudoexfoliation glaucoma
- Mild stage glaucoma defined by glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB with no central 5 degree points worse than 15 dB
- Moderate stage glaucoma defined as either: 1) glaucomatous optic neuropathy and visual field mean deviation between -6.0 dB and -12.0 dB with no central 5 degree points worse than 15 dB, or 2) mean deviation -12.0 dB or better with 1 central 5 degree point worse than 15 dB
- Medicated intraocular pressure between 10 and 31 mm Hg at time of surgery decision
- Willing and able to understand and provide informed consent
- Willing and able to attend all postoperative examinations per protocol schedule
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 of 180 degrees or greater
- Peripheral anterior synechiae in nasal or inferior angle
- Best corrected visual acuity worse than 20/200
- Phacodonesis detected on pre-operative exam
- Vitreous present in anterior chamber on pre-operative exam
- Nanophthalmos
- Use of anti-platelet or anticoagulant medications other than aspirin 81mg daily
- Active treatment for another eye condition in either eye, such as anti-VEGF injections or steroids for corneal transplant
- Abnormalities in study eye affecting tonometry
- Glaucoma diagnoses other than mild/moderate open-angle glaucoma
- Normal tension glaucoma
- Conditions causing elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
- History of uveitis in either eye
- Inability to complete gonioscopy examination
- Use or anticipated use of oral steroids within 90 days
- Use of oral medications affecting intraocular pressure like acetazolamide or methazolamide
- History of steroid-associated intraocular pressure elevation
- Medically unfit for attending planned study visits
- Participation in another interventional research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo cataract surgery combined with one of the glaucoma procedures: Hydrus Microstent insertion, incisional goniotomy, or excisional goniotomy.
1 surgery visit and immediate post-operative assessment
Duration - Up to 3 years
Participants attend follow-up visits to monitor recovery, intraocular pressure, medication use, and any surgical complications.
Regularly scheduled follow-up visits over 3 years
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
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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