XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

Inclusion Criteria:

• Open-angle glaucoma where the intraocular pressure (IOP) is not controlled when usingtopical IOP-lowering glaucoma medication
• Best-corrected baseline Snellen visual acuity of 20/100 or better
• Visual field mean deviation no worse than -18.0 decibels (dB)
• Medicated IOP ≥15 millimeter of mercury (mm Hg) and ≤44 mm Hg
• Participants not anticipated to require any ocular surgery (e.g., cataract surgery) ineither eye up to 3 months from the time of inclusion
• Area of healthy, free, and mobile conjunctiva in the target area (superior bulbarconjunctiva)
• Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the targetquadrant)
• Failed ab-interno canal or suprachoroidal micro invasive glaucoma surgery (MIGS)procedures (such as i-Stent, gonioscopy-assisted transluminal trabeculotomy [GATT],Ab-interno canaloplasty [ABiC], Kahook dual blade goniotomy, etc.) are allowed ≥3months before enrollment. CyPass® Micro-Stents were not allowed.

Exclusion Criteria:

• Participant has active neovascular, uveitic or angle recession glaucoma or anyglaucoma associated with vascular disorders
• Participant has had prior ab externo incisional glaucoma surgery (such astrabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagenimplants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy,ultrasound circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle)
• Clinically significant inflammation or infection within 30 days before thepreoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease,keratitis, uveitis, herpes simplex infection)
• Presence of conjunctival scarring or prior conjunctival surgery or other conjunctivalpathologies (e.g., pterygium) in the target area
• History of corneal surgery, corneal opacities, or corneal disease
• Central corneal thickness ≤490 micrometer (μm) or ≥620μm
• Vitreous present in the anterior chamber
• Aphakic
• Participant has had prior intraocular surgery in either eye within ≤3 months beforethe preoperative visit (including phacoemulsification)
• History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreousloss, anterior chamber intraocular lens [ACIOL], perhaps sutured intraocular lens [IOL] or scleral fixated IOL, prior cystoid macular edema [CME], etc.)
• Presence of intraocular silicone oil
• Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization,branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, orother ophthalmic disease or disorder that could confound study results or impairedepiscleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger,iridocorneal endothelial syndrome [ICE], etc.)
• Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcineproducts, or glutaraldehyde)
• Pregnant or nursing women and those planning a pregnancy during the study period.
• Participation in another drug or device clinical trial concluding within 30 daysbefore the preoperative visit