What is this study of Hydrus Microstent and goniotomy surgeries trying to find out about glaucoma?

This study is evaluating how three different microinvasive glaucoma surgeries compare in lowering eye pressure and their safety when combined with cataract surgery. Researchers want to understand which surgical approach may work best for patients with mild to moderate open-angle glaucoma. The Massachusetts Eye and Ear Infirmary is leading this research to improve glaucoma treatment options.

Who may be eligible for this glaucoma clinical trial?

Adults aged 40 to 85 with mild to moderate open-angle glaucoma and a cataract planned for surgery may be eligible. Participants must have specific eye pressure levels and be able to attend all follow-up visits. People with prior certain glaucoma surgeries or other eye conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this glaucoma clinical trial?

Study-related care, including the surgical procedures and all trial visits, is provided at no cost. However, personal travel expenses to and from the study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs during the study.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 85Years

All Genders

ID06289491

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

Research Sites

104 weeks

Total Duration

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

Age: 40Years - 85Years

All Genders

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

Research Team

Michael M Lin, MD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here