Efficacy and Safety of XEN63 Gel Implant

Prior treatment

• Previous trabeculectomy or valve or tube placement.
• Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant.
• Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery

Other illness

• Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos)
• Known or suspected allergy or sensitization to medications required for the surgical procedure or some component of the device (e.g. glutaraldehyde or porcine derivatives)
• History of predisposition to the formation of keloids.

Other

• Closed-angle glaucoma
• Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
• Anterior chamber lenses
• Presence of intraocular silicone oil
• Vitreous in anterior chamber
• Pregnancy or breastfeeding.

• Age ≥ 18 years
• Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
• Need for XEN63 implantation for IOP not controlled by medical therapy, progression of disease or intolerance to topical therapy, in association or not with cataract surgery.
• Informed consent freely given and obtained before the start of the study.
• The participant has the ability to understand and the willingness to follow the study instructions and is likely to complete all required visits and procedures.