Status:
COMPLETED
Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma
Lead Sponsor:
Xerencia de Xestión Integrada de Ferrol
Collaborating Sponsors:
University Hospital Complex of Santiago de Compostela
Conditions:
Pseudoexfoliation Syndrome
Pseudoexfoliation Glaucoma in Both Eyes
Eligibility:
All Genders
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 limite...
Eligibility Criteria
Inclusion
- 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
- Patients with follow up less than 12 months.
- Patients with end-stage glaucoma, uveitic and angle closure glaucoma.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06993311
Start Date
January 1 2018
End Date
December 31 2022
Last Update
May 28 2025
Active Locations (1)
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1
Sara Pose-Bazarra
Ferrol, Spain