Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.

Inclusion Criteria:

• Diagnosis of primary open angle glaucoma
• Participants are taking at least one and no more than four topical IOP-lowering medications.

Exclusion Criteria:

• Angle Closure Glaucoma
• Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
• Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
• Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant