Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

NCT06993311 | Completed

• 1 other identifier: XENPXF
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pseudoexfoliation Syndrome; Pseudoexfoliation Glaucoma in Both Eyes; Open Angle Glaucoma

Keywords

Xen

Outcome Measures

Primary Outcomes (1)

• INTRAOCULAR PRESSURE

  The primary outcome measure will be intraocular pressure reduction at final follow up

  12-48 months

Secondary Outcomes (6)

• NUMBER OF TREATMENTS

  12-48 months

• BEST CORRECTED VISUAL ACUITY

  12-48 months

• RETINAL NERVE FIBER LAYER

  12-48 months

• RATES OF REINTERVENTION

  12-48 months

• INCIDENCE OF TREATMENT ADVERSE EVENTS

  12-48 months

Study Arms (2)

Pseudoexfoliation glaucoma

Device: Xen Gel Stent implantation

Open-angle glaucoma

Device: Xen Gel Stent implantation

Interventions

Xen Gel Stent implantation DEVICE

Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022

Open-angle glaucoma; Pseudoexfoliation glaucoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected for all patients with PXFG, POAG and other secondary OAG, who underwent surgery from 2018 to 2022, at 2 terciary care academic ophthalmology centers (University Hospital Complex of Ferrol and University Hospital Complex of Santiago de Compostela, Spain) by 10 surgeons.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xerencia de Xestión Integrada de Ferrol: lead
• University Hospital Complex of Santiago de Compostela: collaborator

Study Sites (1)

Sara Pose-Bazarra

Ferrol, Spain

Location

MeSH Terms

Conditions

Exfoliation Syndrome; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Glaucoma; Ocular Hypertension

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist MD

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: May 28, 2025
• Study Start: January 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)