A Trial of Hydrus Microstent Versus Goniotomy

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