Efficacy and Safety of XEN63 Gel Implant

Efficacy and Safety of the XEN63: a Prospective Observational Multicenter Study.

The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.

The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation. Every patients will be followed for 24 months.

Secondary aims of the study are:

• Evaluating the hypotensive efficacy of the XEN63 12 months after implantation.
• Assessing the safety of the XEN63 device after 12 and 24 months after implantation.
• Comparing the hypotensive efficacy of the XEN63 in glaucomatous patients undergoing the solo procedure and in those undergoing the combo procedure
• Evaluating the quality of life of patients undergoing XEN63 implantation 12 and 24 months after implantation.
• Evaluating the association between factors related to the patient, the surgical technique or post-operative management and the hypotensive efficacy of the device during follow-up.

Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
3. 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.
4. Informed consent freely given and obtained before the start of the study.
5. 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.

Exclusion Criteria:

1. Closed-angle glaucoma
2. Previous trabeculectomy or valve or tube placement.
3. Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant.
4. Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
5. Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery
6. Anterior chamber lenses
7. Presence of intraocular silicone oil
8. Vitreous in anterior chamber
9. Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos)
10. 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)
11. History of predisposition to the formation of keloids.
12. Pregnancy or breastfeeding.