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Retro- and prospective, single-center study to evaluate the safety and effectiveness 3 years after the XEN 45 stent implantation

Retro- and prospective, single-center study to evaluate the safety and effectiveness 3 years after the XEN 45 stent implantation - XEN-Longterm-Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023619
Enrollment
40
Registered
2020-12-01
Start date
2020-12-03
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H40.1 H17

Interventions

Group 1: All naive patients after implantation of a XEN 45 micro stent in at least one eye will be examined once postoperatively on an outpatient basis with regard to safety and the glaucoma stage. Th

Sponsors

Dietrich Bonhoeffer Klinikum, Klinik für Augenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: - Patients 2 to 5 years after implantation of a XEN 45 stent (2013-2018) - Willingness of patients to participate in the study and written consent.

Exclusion criteria

Exclusion criteria: - Patients with a distant place of residence or with a limited general condition due to illness, who cannot be expected to travel to Neubrandenburg. - Patients who have moved unknown. - Deceased patients (existing data are documented). - Patients who are not interested in participating in the study

Design outcomes

Primary

MeasureTime frame
Determination of the effect of the XEN 45 microstent implantation on intraocular pressure, the number of necessary antiglaucomatous therapies, the progression of glaucoma in terms of visual field deterioration and progression of glaucomatous papillary changes and the loss of endothelial cells.

Secondary

MeasureTime frame
Safety of the procedure based on the intra- and post-operative complications that have occurred. Development of the stent-associated conjunctival filtering bleb, Long-term success rate of the XEN 45 stent Clinical identification of stent failure.

Countries

Germany

Contacts

Public ContactUlrike Holland

Diakonie Klinikum Dietrich Bonhoeffer GmbH

aug-st2@dbknb.de0395/775-13427

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026