Primary Open Angle GlaucomaNCT05439161
XEN Glaucoma Gel Stent Versus Trabeculectomy
A study testing surgery in people with Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Prof. Dr. Herbert Reitsamer at 1 site in Austria.
Trial summary
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Dispersion Glaucoma
- What is being tested?
- surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteAustria
- Study dates
- 20 Dec 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
- Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the superior nasal target quadrant)
- VA logMAR ≤ 1 (VA dec ≥ 0.1)
- Trabecular meshwork must be visible (with Shaffer angle grade > 1 in the target quadrant)
- Age 18 years or older
- Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent
Who cannot join
- Clinical significant cataract
- Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
- Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
- Phacic Angle Closure Glaucoma
- Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
Show all 15Show fewer
- Anterior chamber intraocular lens
- Vitreous present in the anterior chamber
- Presence of intraocular silicone oil
- History of corneal surgery, corneal opacities, or corneal disease
- Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
- History of dermatologic keloid formation
- Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, or other ophthalmic disease or disorder that could confound study results
- Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde),
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Dept. Ophthalmology and Optometry Paracelsus Medical University
Salzburg, 5020
Markus Lenzhofer, MD PhD, +43 5 7255 ext. 24201, m.lenzhofer@salk.at
About this study
Official title: Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
Read the detailed description
The objective of this study is to evaluate the postoperative best corrected visual acuity and refraction in 2 different filtering glaucoma surgeries: XEN implant standalone procedure versus classic trabeculectomy standalone procedure. Both procedures are standard of care in surgical treatment of glaucoma. The XEN implant is a minimally invasive procedure and spares out the dissection of the conjunctiva, while the classic trabeculectomy is a procedure ab externo and supposed to be more invasive.
Up to 196 eyes will be enrolled in both surgery groups. Patients have to be legible for both procedures and are randomly allocated to both groups. Patients, who need a combined cataract procedure are not legible.
A prospective, randomized, multicenter trial. Four study centers in Europe (Austria) will participate.
Patients with open angle glaucoma will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for the ocular condition. During screening it will be determined via randomization if the subject will be included in group 1 where the XEN implant will be implanted in a standalone procedure or in group 2 where the trabeculectomy will be performed in a standalone procedure. Regardless of study group, all eligible patients will have the same inclusion/exclusion criteria, effectiveness endpoints and follow up exams. An inclusion of both eyes of the same patient is not possible.
Postoperatively, subjects will undergo ophthalmic evaluations at regular intervals as specified in this protocol.
The objective of this study is to evaluate the postoperative best corrected distance and near visual acuity and refraction in 2 different filtering glaucoma surgeries: XEN Implant standalone procedure versus classic trabeculectomy standalone procedure.
The primary endpoint is the proportion of patients with a best corrected distance visual acuity > 0.3 (logMAR) after 1 week.
Secondary objectives are the distance and near best corrected visual acuity measured at postoperative visits (e.g. day 1, month 1, 3, 12) and relative change of visual acuity at postoperative visits compared to baseline in both groups (e.g. month 1). The proportion of patients with a loss of best corrected distance visual acuity ≥ 2 lines at postoperative visits (e.g. day 1), the proportion of patients with a best corrected distance visual acuity (logMAR) > 0.3 and > 0.5 will be assessed at different postoperative visits (e.g. week 1, 2, month 1 and 3). Additionally, the time of recovery of visual acuity and the postoperative changes of refraction after the procedures will be compared. Secondary endpoints also include efficacy and safety of both procedures.
Subjects will undergo study visits at the following times: Preoperative Visit 1 (Screening), Operative Visit 2, 1 Day, 1 Week, 2 Weeks, 1 Month, 3, 6 Months, 12 Months Visit.
- Being tested
- surgery
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryDevice
2 types of filtering glaucoma surgeries (classic trabeculectomy as gold standard, and newer XEN glaucoma microstent) are compared against each other in a prospective multicentric randomized study
| Study group | Role | What they receive |
|---|---|---|
| XEN Glaucoma Gel Microstent (AbbVie) Device | Active comparator | Implantation of XEN Glaucoma Gel Microstent (Device, AbbVie) for the treatment of glaucoma will be performed in this arm. It is a newer filtering glaucoma surgery. XEN Glaucoma Gel Microstent implantation accounts to the filtering glaucoma surgeries. Receives: Device: surgery |
| Trabeculectomy | Active comparator | Trabeculectomy will be performed in this arm. Trabeculecomy is the classic filtering glaucoma surgery since more than 50 years for the treatment of glaucoma (gold standard within the filtering glaucoma surgery group). Receives: Device: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Distance Visual Acuity at 1 Week
The primary endpoint is the proportion of patients with a best corrected distance visual acuity > 0.3 (logMAR) after 1 week.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start20 Dec 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Herbert Reitsamer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Herbert Reitsamer, Paracelsus Medical University
- Investigators
- Herbert Reitsamer, MD, Study chair, Paracelsus Medical University Salzburg/ Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439161
- Sponsor's protocol ID
- A.08242018-v2.15122021
- Status last verified
- May 2025
- First submitted
- 15 Jun 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
- ClinicalTrials.gov ID
- NCT05439161
- Acronym / sponsor ID
- A.08242018-v2.15122021
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Prof. Dr. Herbert ReitsamerUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Jun 2022 (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.
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
Detailed description
The objective of this study is to evaluate the postoperative best corrected visual acuity and refraction in 2 different filtering glaucoma surgeries: XEN implant standalone procedure versus classic trabeculectomy standalone procedure. Both procedures are standard of care in surgical treatment of glaucoma. The XEN implant is a minimally invasive procedure and spares out the dissection of the conjunctiva, while the classic trabeculectomy is a procedure ab externo and supposed to be more invasive.
Up to 196 eyes will be enrolled in both surgery groups. Patients have to be legible for both procedures and are randomly allocated to both groups. Patients, who need a combined cataract procedure are not legible.
A prospective, randomized, multicenter trial. Four study centers in Europe (Austria) will participate.
Patients with open angle glaucoma will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for the ocular condition. During screening it will be determined via randomization if the subject will be included in group 1 where the XEN implant will be implanted in a standalone procedure or in group 2 where the trabeculectomy will be performed in a standalone procedure. Regardless of study group, all eligible patients will have the same inclusion/exclusion criteria, effectiveness endpoints and follow up exams. An inclusion of both eyes of the same patient is not possible.
Postoperatively, subjects will undergo ophthalmic evaluations at regular intervals as specified in this protocol.
The objective of this study is to evaluate the postoperative best corrected distance and near visual acuity and refraction in 2 different filtering glaucoma surgeries: XEN Implant standalone procedure versus classic trabeculectomy standalone procedure.
The primary endpoint is the proportion of patients with a best corrected distance visual acuity > 0.3 (logMAR) after 1 week.
Secondary objectives are the distance and near best corrected visual acuity measured at postoperative visits (e.g. day 1, month 1, 3, 12) and relative change of visual acuity at postoperative visits compared to baseline in both groups (e.g. month 1). The proportion of patients with a loss of best corrected distance visual acuity ≥ 2 lines at postoperative visits (e.g. day 1), the proportion of patients with a best corrected distance visual acuity (logMAR) > 0.3 and > 0.5 will be assessed at different postoperative visits (e.g. week 1, 2, month 1 and 3). Additionally, the time of recovery of visual acuity and the postoperative changes of refraction after the procedures will be compared. Secondary endpoints also include efficacy and safety of both procedures.
Subjects will undergo study visits at the following times: Preoperative Visit 1 (Screening), Operative Visit 2, 1 Day, 1 Week, 2 Weeks, 1 Month, 3, 6 Months, 12 Months Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XEN Glaucoma Gel Microstent (AbbVie) Device | Active comparator | Device: surgeryImplantation of XEN Glaucoma Gel Microstent (Device, AbbVie) for the treatment of glaucoma will be performed in this arm. It is a newer filtering glaucoma surgery. XEN Glaucoma Gel Microstent implantation accounts to the filtering glaucoma surgeries. |
| Trabeculectomy | Active comparator | Device: surgeryTrabeculectomy will be performed in this arm. Trabeculecomy is the classic filtering glaucoma surgery since more than 50 years for the treatment of glaucoma (gold standard within the filtering glaucoma surgery group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
- Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the superior nasal target quadrant)
- VA logMAR ≤ 1 (VA dec ≥ 0.1)
- Trabecular meshwork must be visible (with Shaffer angle grade > 1 in the target quadrant)
- Age 18 years or older
Key exclusion criteria (15 listed)
- Clinical significant cataract
- Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
- Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
- Phacic Angle Closure Glaucoma
- Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
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 |
|---|---|---|
| surgery2 types of filtering glaucoma surgeries (classic trabeculectomy as gold standard, and newer XEN glaucoma microstent) are compared against each other in a prospective multicentric randomized study | Device | Trabeculectomy, XEN Glaucoma Gel Microstent (AbbVie) Device |
Primary outcome
Best Corrected Distance Visual Acuity at 1 Week
Time frame: Week 1
The primary endpoint is the proportion of patients with a best corrected distance visual acuity > 0.3 (logMAR) after 1 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- 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.
Herbert Reitsamer, MD study chair
Paracelsus Medical University Salzburg/ Salzburger Landeskliniken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Prof. Dr. Herbert Reitsamer at 1 site in Austria.
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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Jun 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Markus Lenzhofer, MD PhD (+43 5 7255 ext. 24201, m.lenzhofer@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Distance Visual Acuity at 1 Week (time frame: Week 1). 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 3 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.