Pseudoexfoliation SyndromeNCT06993311
Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma
An observational study of Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma in Both Eyes, run by Xerencia de Xestión Integrada de Ferrol at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudoexfoliation Syndrome, Pseudoexfoliation Glaucoma in Both Eyes, Open Angle Glaucoma
- What is being tested?
- Xen Gel Stent implantation
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with follow up less than 12 months.
- Patients with end-stage glaucoma, uveitic and angle closure glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four-year Outcomes of Minimally Invasive XEN Gel Stent Implantation in Pseudoexfoliation Glaucoma: Real World Evidence
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.
- Being tested
- Xen Gel Stent implantation
- Keywords
- Xen
- Medical subject headings
- Exfoliation Syndrome, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xen Gel Stent implantationDevice
Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022
| Study group | Role | What they receive |
|---|---|---|
| Pseudoexfoliation glaucoma | Not described Receives: Device: Xen Gel Stent implantation | |
| Open-angle glaucoma | Not described Receives: Device: Xen Gel Stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTRAOCULAR PRESSURE
The primary outcome measure will be intraocular pressure reduction at final follow up
Measured: 12-48 months
Secondary outcomes (6)
NUMBER OF TREATMENTS
Number of glaucoma drugs: Investigate the reduction of drugs after surgery
Measured: 12-48 months
BEST CORRECTED VISUAL ACUITY
Best-corrected visual acuity (BCVA): investigators will compare the change of visual acuities (VA) between pre-surgery to last follow-up
Measured: 12-48 months
RETINAL NERVE FIBER LAYER
Retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT): investigators will compare the reduction in the retinal nerve fiber layer by OCT according to the analysis of glaucoma (Heidelberg)
Measured: 12-48 months
RATES OF REINTERVENTION
Number of trabeculectomy or filtering surgery required as a result of poor control of IOP
Measured: 12-48 months
INCIDENCE OF TREATMENT ADVERSE EVENTS
Investigators will determine the safety profile of the intervention through an evaluation of intraoperative and post-operative complications. All adverse events or complications related to the intervention will be recorded in a descriptive manner.
Measured: 12-48 months
PRESERVATIVES EXPOSURE
Investigators will collect data on pre-surgery treatment regarding the use or non-use of preservatives and their exposure time to these drugs to compare effectiveness outcomes in both groups.
Measured: 12-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2018
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoexfoliation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xerencia de Xestión Integrada de Ferrol
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Complex of Santiago de Compostela
- Responsible party
- Principal investigator, SARA POSE BAZARRA, Xerencia de Xestión Integrada de Ferrol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993311
- Sponsor's protocol ID
- XENPXF
- Status last verified
- May 2025
- First submitted
- 31 May 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-year Outcomes of Minimally Invasive XEN Gel Stent Implantation in Pseudoexfoliation Glaucoma: Real World Evidence
- ClinicalTrials.gov ID
- NCT06993311
- Acronym / sponsor ID
- XENPXF
- Keywords
- Xen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Xerencia de Xestión Integrada de FerrolUniversity, hospital or other
- Collaborators
- University Hospital Complex of Santiago de Compostela
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pseudoexfoliation glaucoma | – | Device: Xen Gel Stent implantation |
| Open-angle glaucoma | – | Device: Xen Gel Stent implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with follow up less than 12 months.
- Patients with end-stage glaucoma, uveitic and angle closure glaucoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xen Gel Stent implantationConsecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022 | Device | Open-angle glaucoma, Pseudoexfoliation glaucoma |
Primary outcome
INTRAOCULAR PRESSURE
Time frame: 12-48 months
The primary outcome measure will be intraocular pressure reduction at final follow up
6 secondary outcomes
NUMBER OF TREATMENTS
Time frame: 12-48 months
BEST CORRECTED VISUAL ACUITY
Time frame: 12-48 months
RETINAL NERVE FIBER LAYER
Time frame: 12-48 months
RATES OF REINTERVENTION
Time frame: 12-48 months
INCIDENCE OF TREATMENT ADVERSE EVENTS
Time frame: 12-48 months
PRESERVATIVES EXPOSURE
Time frame: 12-48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma in Both Eyes, run by Xerencia de Xestión Integrada de Ferrol at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INTRAOCULAR PRESSURE (time frame: 12-48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.