NCT06289491Recruiting
A Trial of Hydrus Microstent Versus Goniotomy
Randomized Trial of Hydrus Microstent Versus Goniotomy
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 243 (estimated)
- First submitted
- 25 Feb 2024
- Start date
- 14 Feb 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Diseases
- Glaucoma
- NCT number
- NCT06289491
What you commit to
- Study type: Interventional
- Planned participants: 243
- From 14 Feb 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Anti-platelet and anticoagulant medications other than aspirin 81mg daily
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts Eye and Ear Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.