XEN Glaucoma Gel Stent Versus Trabeculectomy

Prior treatment

• Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.

Other illness

• Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
• History of corneal surgery, corneal opacities, or corneal disease
• History of dermatologic keloid formation
• Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, or other ophthalmic disease or disorder that could confound study results
• Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde),

Lab values

• Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)

Other

• Clinical significant cataract
• Phacic Angle Closure Glaucoma
• Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
• Anterior chamber intraocular lens
• Vitreous present in the anterior chamber
• Presence of intraocular silicone oil
• Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
• Pregnant or nursing women

• Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
• Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the superior nasal target quadrant)
• VA logMAR ≤ 1 (VA dec ≥ 0.1)
• Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
• Age 18 years or older
• Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent