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

NCT07350200 | Completed

• 1 other identifier: 5/WIM/2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Keywords

Glaucoma; XEN glaucoma implant; Uncontrolled Glaucoma

Outcome Measures

Primary Outcomes (3)

• IOP

  Intraocular Pressure

  through study completion, an average of 5 years

• BCVA

  The change of best- corrected visual acuity

  through study completion, an average of 5 years

• Visual Field

  Visual Field of the mean defect

  through study completion, an average of 5 years

Secondary Outcomes (1)

• Medications

  through study completion, an average of 5 years

Study Arms (1)

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma

EXPERIMENTAL

Group of patients, who underwent XEN implantation and had a history of previous unsuccessful antiglaucoma procedures, and who were subject to surgeries performed by the same experienced surgeon.

Procedure: XEN implantation

Interventions

XEN implantation PROCEDURE

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.

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of OUG, defined as prior treatment with surgical or cyclodestructive procedures
• failure to achieve target IOP with maximally tolerated topical IOP-lowering treatment or intolerance to drugs
• both primary and secondary open- and closed-angle glaucoma cases
• presence of healthy mobile conjunctiva in at least one quadrant and bestcorrected visual acuity

You may not qualify if:

• presence of clinically significant inflammation or infection within 30 days before surgery, history of corneal refractive surgery, corneal deposits or haze preventing intraoperative viewing of the anterior chamber, presence of an anterior chamber lens, advanced age-related macular degeneration (AMD), known or suspected allergy or sensitivity to porcine products or glutaraldehyde, pregnant or nursing women, and lack of consent to participate in the study

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine - National Research Institute

Warsaw, 04-141, Poland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 20, 2026
• Study Start: December 2, 2014
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: January 20, 2026

Record last verified: 2014-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)