Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma

Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

Inclusion Criteria:

• diagnosis of primary open angle glaucoma
• trabecular meshwork visible in gonioscopy
• medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg
• taking 1 to 5 IOP-lowering medications
• area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)
• signed inform consent

Exclusion Criteria:

• angle closure glaucoma
• secondary open angle glaucoma
• previous glaucoma shunt/valve in the target quadrant
• presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
• active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
• active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
• anterior chamber intraocular lens
• presence of intraocular silicone oil
• vitreous present in the anterior chamber
• impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
• 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)
• history of dermatologic keloid formation
• previous photorefractive keratectomy