Trials / Enrolling By Invitation

Enrolling By InvitationNCT06844240

Efficacy and Safety of XEN63 Gel Implant

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

Status: Enrolling By Invitation
Phase: —
Study type: Observational
Enrollment: 96 (estimated)

Sponsor: Mario Stirpe · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

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.

Conditions

Glaucoma

Timeline

Start date: 2024-11-28
Primary completion: 2030-12-31
Completion: 2030-12-31
First posted: 2025-02-25
Last updated: 2025-02-25

Locations

19 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT06844240. Inclusion in this directory is not an endorsement.