NCT06993311

Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

Four-year Outcomes of Minimally Invasive XEN Gel Stent Implantation in Pseudoexfoliation Glaucoma: Real World Evidence

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Xerencia de Xestión Integrada de Ferrol · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The Xen implant is an ab interno device that has been shown to be effective in reducing intraocular pressure in several types of glaucoma, although the evidence in pseudoexfoliative glaucoma is limited. The present retrospective observational study aims to increase knowledge about the long-term effectiveness and safety of the implant in pseudoexfoliative glaucoma. Researchers will compare the results with data from patients with open-angle glaucoma.

Conditions

• Pseudoexfoliation Syndrome
• Pseudoexfoliation Glaucoma in Both Eyes
• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Xen Gel Stent implantation	Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-31
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: Spain