Primary Open Angle GlaucomaNCT07235592
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
An observational study of Primary Open Angle Glaucoma, run by Santen SAS at 12 sites in 8 countries.
Trial summary
The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Microshunt XI
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 19 Mar 2026to Sep 2027
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the subject is included in the study and relevant data will be recorded during scheduled clinical visits. Participation in this study is entirely voluntary;
Who may be able to join
- Male or female, age 18 to 85 years, inclusive
- Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications
- Patient willing to comply with study requirements
- Patient who has signed an approved informed consent form
Who cannot join
- Angle closure glaucoma
- Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)
- Active iris neovascularization
- Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)
- Vitreous in the anterior chamber
- Presence of an anterior chamber intraocular lens (ACIOL)
Show all 17Show fewer
- Intraocular silicone oil
- Need for glaucoma surgery combined with other ocular procedures (e.g., cataract surgery with IOL implantation) or anticipated need for additional ocular surgery during the investigational period
- Central corneal thickness that is less than 450 microns or greater than 620 microns
- Previous cilioablative procedure
- Neovascular glaucoma
- Uveitic Glaucoma
- Pseudoexfoliative or pigmentary glaucoma
- Chronic inflammation
- Previous incisional ophthalmic surgery within 6 months prior to study
- Enrolled in this or another study (only one eye can participate in this study) or completed their participation in another study within 30 calendar days of the screening exam
- Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the patient at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the Protocol
Trial locations and contacts
12 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Santen SAS Clinical Operations contact
12 sites in 8 countries
Italy3 sites, 2 recruiting
- Recruiting
Irccs Fondazione G. B. Bietti
Rome
Dr Francesco Oddone
- Not yet recruiting
Ospedale di Sassuolo
Sassuolo
Prof. Enrico Martini
- Terminated
Policlinico Universitario Molinette
Turin
Germany2 sites, 2 recruiting
- Recruiting
Internationale Innovative Opthalmochirurgie GbR
Düsseldorf
Dr Karsten Klabe
- Recruiting
Universitätsklinikum Tübingen, Department für Augenheilkunde
Tübingen
Prof. Bogomil Voykov
United Kingdom2 sites, 2 recruiting
- Recruiting
Guy's and St. Thomas' NHS Foundation Trust
London
Prof. Kin Sheng Lim
- Recruiting
Moorfields Eye Hospital NHS Foundation Trust
London
Prof. Gus Gazzard
Belgium1 site, 1 recruiting
- Recruiting
Glaucoma Clinic, UZ Leuven
Leuven
Prof. Ingeborg Stalmans
Netherlands1 site, 1 recruiting
- Recruiting
Universiteitskliniek voor Oogheelkunde Maastricht
Maastricht
Prof. Henny Beckers
Portugal1 site, 1 recruiting
- Recruiting
ULS Santa Maria, Lisboa
Lisbon
Prof. Luis Abegao Pinto
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
San Carlos
Prof. Julián García-Feijóo
About this study
Official title: Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma
The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.
Read the detailed description
This is a prospective, multicentric, single arm post market clinical follow-up study to collect safety and performance data on the CE Marked PRESERFLO™ MicroShunt XI device in patients with primary open angle glaucoma. The PRESERFLO™MicroShunt XI employs a tube to create a conduit for the flow of aqueous humor from the anterior chamber of the eye to a bleb formed under the conjunctiva and Tenon's capsule; the front/ proximal end of the tube extends into the anterior chamber while the back/ distal end terminates in the bleb. The PRESERFLO™MicroShunt XI reduces IOP by physically shunting aqueous humor from the high pressure anterior chamber to the lower pressure bleb. The intended users of the PRESERFLO™ MicroShunt XI are ophthalmologists/ophthalmic surgeons specialized in the treatment of glaucoma (including surgeons specialized in anterior segment and cataract surgery) who have been trained to use the device. No biospecimens are collected in this study and no control group.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Microshunt XI
- Keywords
- POAG
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microshunt XIDevice
Also called Intervention Model/Device: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival/Tenon implantation.
The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device
| Study group | Role | What they receive |
|---|---|---|
| Microshunt XI treatment group | MicroShunt XI will be surgically implanted in eyes of patients with primary open angle glaucoma where intra ocular pressure (IOP) remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. Receives: Device: Microshunt XI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
This is a primary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to <21 mmHg intraocular pressure from screening to 12 months
Measured: Screening to 12 months
Secondary outcomes (1)
Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
This is a secondary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to <18 mmHg intraocular pressure at 12 months
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start19 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235592
- Sponsor's protocol ID
- 200011001SW
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07235592
- Acronym / sponsor ID
- 200011001SW
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- POAG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Nov 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 purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.
Detailed description
This is a prospective, multicentric, single arm post market clinical follow-up study to collect safety and performance data on the CE Marked PRESERFLO™ MicroShunt XI device in patients with primary open angle glaucoma. The PRESERFLO™MicroShunt XI employs a tube to create a conduit for the flow of aqueous humor from the anterior chamber of the eye to a bleb formed under the conjunctiva and Tenon's capsule; the front/ proximal end of the tube extends into the anterior chamber while the back/ distal end terminates in the bleb. The PRESERFLO™MicroShunt XI reduces IOP by physically shunting aqueous humor from the high pressure anterior chamber to the lower pressure bleb. The intended users of the PRESERFLO™ MicroShunt XI are ophthalmologists/ophthalmic surgeons specialized in the treatment of glaucoma (including surgeons specialized in anterior segment and cataract surgery) who have been trained to use the device. No biospecimens are collected in this study and no control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microshunt XI treatment group | – | Device: Microshunt XIMicroShunt XI will be surgically implanted in eyes of patients with primary open angle glaucoma where intra ocular pressure (IOP) remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the subject is included in the study and relevant data will be recorded during scheduled clinical visits. Participation in this study is entirely voluntary;
Key inclusion criteria (4 listed)
- Male or female, age 18 to 85 years, inclusive
- Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications
- Patient willing to comply with study requirements
- Patient who has signed an approved informed consent form
Key exclusion criteria (17 listed)
- Angle closure glaucoma
- Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)
- Active iris neovascularization
- Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)
- Vitreous in the anterior chamber
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 |
|---|---|---|
| Microshunt XIAlso: Intervention Model/Device: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival/Tenon implantation.The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device | Device | Microshunt XI treatment group |
Primary outcome
Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
Time frame: Screening to 12 months
This is a primary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to <21 mmHg intraocular pressure from screening to 12 months
1 secondary outcome
Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
Time frame: At 12 months
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 28 Oct 2026.
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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.
Santen SAS Clinical Operations contact
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Santen SAS at 12 sites in 8 countries.
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 17 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Germany, United Kingdom, Austria, Belgium and 3 more countries. 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 Study Director / Medical Monitor Raymund Angeles (510-368-9861, raymund.angeles@santen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure (time frame: Screening to 12 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 Oct 2026.