Clinical trial NCT06289491: A Trial of Hydrus Microstent Versus Goniotomy
Official title: Randomized Trial of Hydrus Microstent Versus Goniotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Glaucoma, Open-Angle
Keywords: Incisional goniotomy
Excisional goniotomy
Hydrus Microstent
Goniotomy
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 243
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
* 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
* Anti-platelet and anticoagulant medications other than aspirin 81mg daily
* Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
* Abnormality in study eye that could affect tonometry
* Glaucoma diagnosis other than the above
* Normal tension glaucoma
* Conditions that can cause 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 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
* History of steroid-associated IOP elevation
* Medically unfit for attending planned study visits
* Involvement in another interventional research study

Primary outcomes:
measure: Intraocular pressure
timeFrame: 3 years
measure: Intraocular pressure-lowering medications
timeFrame: 3 years
Secondary outcomes:
measure: Surgical complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
References: