ClinicalTrials.Veeva

Menu

Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

X

Xerencia de Xestión Integrada de Ferrol

Status

Completed

Conditions

Pseudoexfoliation Syndrome
Open Angle Glaucoma
Pseudoexfoliation Glaucoma in Both Eyes

Treatments

Device: Xen Gel Stent implantation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

350 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Data will be collected for all patients with pseudoexfoliation glaucoma (PXFG), ocular hypertension (OHT) and pseudoexfoliation syndrome, POAG and other secondary open angle glaucoma (OAG) diagnosed, who underwent surgery from 2018 to 2022.

Patients should be candidates for filtering glaucoma surgery for the following indications:

  • uncontrolled intraocular pressure (IOP)
  • intolerance or non-adherence to topical treatment
  • glaucoma progression despite topical therapy
  • surgical cataract patients undergoing phacoemulsification, who were treated with two or more hypotensive drugs and wished to withdraw the medication due to side effects and/or discomfort of the treatment.

Refractory glaucoma and eyes with previous filtering surgery, previous laser treatments or micropulse transscleral cyclophotocoagulation will be also included.

Exclusion criteria

  • Patients with follow up less than 12 months.
  • Patients with end-stage glaucoma, uveitic and angle closure glaucoma.

Trial design

350 participants in 2 patient groups

Pseudoexfoliation glaucoma
Treatment:
Device: Xen Gel Stent implantation
Open-angle glaucoma
Treatment:
Device: Xen Gel Stent implantation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems