Effectiveness and safety of the XEN63 gel implAnt in indiviDUals with primary open-angle glaucoma: a German retrospective real-world study

Effectiveness and safety of the XEN63 gel implAnt in indiviDUals with primary open-angle glaucoma: a German retrospective real-world study - XENADU

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034552

Enrollment

300

Registered

2024-12-19

Start date

2025-01-31

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

H40.1

Interventions

Group 1: Patients with primary open-angle glaucoma that were implanted with the XEN63 gel stent.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Diagnosis of POAG, • At least one IOP-lowering medication.

Exclusion criteria

Exclusion criteria: • Cataract surgery concomitant to XEN implantation, • Previous vitrectomy or glaucoma surgery requiring conjunctival incision/manipulation, • Any other contra-indication for XEN implantation.

Design outcomes

Primary

Measure	Time frame
• Intraocular pressure (IOP) at baseline and month 6 after XEN63 implantation, • Number of topical IOP-lowering medications at baseline and month 6 after XEN63 implantation.	—

Secondary

Measure	Time frame
• IOP at baseline and month 12 after XEN63 implantation, • Number of topical IOP-lowering medications at baseline and month 12 after XEN63 implantation, • Number of bleb needlings, • Time to first bleb needling, • Number of open revisions, • Time to open revision, • Secondary surgical interventions for IOP reduction, • Time to secondary surgical interventions for IOP reduction, • Post-operative adverse events of special interest (AESIs).	—

Measure

Time frame

• IOP at baseline and month 12 after XEN63 implantation, • Number of topical IOP-lowering medications at baseline and month 12 after XEN63 implantation, • Number of bleb needlings, • Time to first bleb needling, • Number of open revisions, • Time to open revision, • Secondary surgical interventions for IOP reduction, • Time to secondary surgical interventions for IOP reduction, • Post-operative adverse events of special interest (AESIs).

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026