A Trial of Hydrus Microstent Versus Goniotomy
Key facts
- Where
- Boston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Source: NCT06289491, who can take part
Where in United States
- Massachusetts Eye and EarBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts Eye and Ear Infirmary
- Trial code
- NCT06289491
- Record updated
- 30 March 2026
- Original description
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:Read full original descriptionShow less
Randomized Trial of Hydrus Microstent Versus Goniotomy
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.
Inclusion: Visually significant cataract planned for surgery; Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma; Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees <15 dB; Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points <15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point <15 dB; Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery; Willing and able to understand and provide informed consent; Willing and able to attend postoperative examinations per protocol schedule.
Exclusion: Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation; Use of oral steroids within 90 days or anticipated use of oral steroids; Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide; Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant); Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor); History of uveitis in either eye; History of steroid-associated IOP elevation; Anti-platelet and anticoagulant medications other than aspirin 81mg daily; Selective laser trabeculoplasty within 90 days of study enrollment; Iridotrabecular contact for 180 degrees or greater; Peripheral anterior synechiae in nasal or inferior angle; Best corrected visual acuity worse than 20/200; Phacodonesis on pre-operative examination; Vitreous in anterior chamber on pre-operative examination; Nanophthalmos; Abnormality in study eye that could affect tonometry; Glaucoma diagnosis other than the above; Normal tension glaucoma; Inability to complete gonioscopy examination; Medically unfit for attending planned study visits; Involvement in another interventional research study.