GlaucomaNCT07350200
XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up
A study testing XEN implantation in people with Glaucoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- XEN implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 2 Dec 2014to 27 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of OUG, defined as prior treatment with surgical or cyclodestructive procedures
- failure to achieve target IOP with maximally tolerated topical IOP-lowering treatment or intolerance to drugs
- both primary and secondary open- and closed-angle glaucoma cases
- presence of healthy mobile conjunctiva in at least one quadrant and bestcorrected visual acuity
Who cannot join
- presence of clinically significant inflammation or infection within 30 days before surgery, history of corneal refractive surgery, corneal deposits or haze preventing intraoperative viewing of the anterior chamber, presence of an anterior chamber lens, advanced age-related macular degeneration (AMD), known or suspected allergy or sensitivity to porcine products or glutaraldehyde, pregnant or nursing women, and lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Military Institute of Medicine - National Research Institute
Warsaw, 04-141
About this study
XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up
Read the detailed description
Purpose of the study is to analyze the surgical and refractive outcomes of XEN glaucoma implant, a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Intraocular pressure change, best corrected visual acuity, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes.
- Conditions
- Glaucoma
- Being tested
- XEN implantation
- Keywords
- Glaucoma, XEN glaucoma implant, Uncontrolled Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN implantationProcedure or surgery
The surgeon used the ab interno or ab externo technique for XEN implantation. In cases where only the lower quadrants were accessible, the ab externo access was the technique of choice. All treatments were performed with 40 micrograms of mitomycin C, which was injected under the conjunctiva at least 6mm from the corneal limbus in the projection of the future filtering bleb. If a clinically significant cataract was also observed in a phakic patient, the patient qualified for a combined procedure with phacoemulsification and implantation of an artificial intraocular lens.
| Study group | Role | What they receive |
|---|---|---|
| XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma | Experimental | Group of patients, who underwent XEN implantation and had a history of previous unsuccessful antiglaucoma procedures, and who were subject to surgeries performed by the same experienced surgeon. Receives: Procedure: XEN implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Intraocular Pressure
Measured: through study completion, an average of 5 years
BCVA
The change of best- corrected visual acuity
Measured: through study completion, an average of 5 years
Visual Field
Visual Field of the mean defect
Measured: through study completion, an average of 5 years
Secondary outcomes (1)
Medications
Median number of patients who took medications before surgery and up until the end of the study
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start2 Dec 2014
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350200
- Sponsor's protocol ID
- 5/WIM/2021
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2025
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT07350200
- Acronym / sponsor ID
- 5/WIM/2021
- Conditions
- Glaucoma
- Keywords
- Glaucoma, XEN glaucoma implant, Uncontrolled Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 2 Dec 2014 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 20 Jan 2026 (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.
XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up
Detailed description
Purpose of the study is to analyze the surgical and refractive outcomes of XEN glaucoma implant, a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Intraocular pressure change, best corrected visual acuity, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma | Experimental | Procedure: XEN implantationGroup of patients, who underwent XEN implantation and had a history of previous unsuccessful antiglaucoma procedures, and who were subject to surgeries performed by the same experienced surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of OUG, defined as prior treatment with surgical or cyclodestructive procedures
- failure to achieve target IOP with maximally tolerated topical IOP-lowering treatment or intolerance to drugs
- both primary and secondary open- and closed-angle glaucoma cases
- presence of healthy mobile conjunctiva in at least one quadrant and bestcorrected visual acuity
Key exclusion criteria (1 listed)
- presence of clinically significant inflammation or infection within 30 days before surgery, history of corneal refractive surgery, corneal deposits or haze preventing intraoperative viewing of the anterior chamber, presence of an anterior chamber lens, advanced age-related macular degeneration (AMD), known or suspected allergy or sensitivity to porcine products or glutaraldehyde, pregnant or nursing women, and lack of consent to participate in the study
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 implantationThe surgeon used the ab interno or ab externo technique for XEN implantation. In cases where only the lower quadrants were accessible, the ab externo access was the technique of choice. All treatments were performed with 40 micrograms of mitomycin C, which was injected under the conjunctiva at least 6mm from the corneal limbus in the projection of the future filtering bleb. If a clinically significant cataract was also observed in a phakic patient, the patient qualified for a combined procedure with phacoemulsification and implantation of an artificial intraocular lens. | Procedure or surgery | XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma |
Primary outcome
IOP
Time frame: through study completion, an average of 5 years
Intraocular Pressure
BCVA
Time frame: through study completion, an average of 5 years
The change of best- corrected visual acuity
Visual Field
Time frame: through study completion, an average of 5 years
Visual Field of the mean defect
1 secondary outcome
Medications
Time frame: through study completion, an average of 5 years
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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?
A study testing XEN implantation in people with Glaucoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 4 inclusion and 1 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 20 Jan 2026. 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 Poland. 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?
IOP (time frame: through study completion, an average of 5 years). The study lists 3 primary outcomes in all. 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 20 Jan 2026.