NCT07350200

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Military Institute od Medicine National Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up

Detailed description

Purpose of the study is to analyze the surgical and refractive outcomes of XEN glaucoma implant, a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Intraocular pressure change, best corrected visual acuity, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes.

Conditions

• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	XEN implantation	The surgeon used the ab interno or ab externo technique for XEN implantation. In cases where only the lower quadrants were accessible, the ab externo access was the technique of choice. All treatments were performed with 40 micrograms of mitomycin C, which was injected under the conjunctiva at least 6mm from the corneal limbus in the projection of the future filtering bleb. If a clinically significant cataract was also observed in a phakic patient, the patient qualified for a combined procedure with phacoemulsification and implantation of an artificial intraocular lens.

Timeline

• Start date: 2014-12-02
• Primary completion: 2025-11-27
• Completion: 2025-11-27
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Poland