Recruiting
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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.
ClinicalTrials.gov IDNCT07235592
PhaseNot Applicable
Enrollment112
SponsorSanten SAS
Age18 Years – 85 Years
SexALL
About this study
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.
Interventions
- Device: Microshunt XI — The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device
Primary outcomes
- Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure (Screening to 12 months)
Eligibility information
Inclusion Criteria:
1. Male or female, age 18 to 85 years, inclusive
2. 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
3. Patient willing to comply with study requirements
4. Patient who has signed an approved informed consent form
Exclusion Criteria:
1. Angle closure glaucoma
2. Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)
3. Active iris neovascularization
4. Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)
5. Vitreous in the anterior chamber
6. Presence of an anterior chamber intraocular lens (ACIOL)
7. Intraocular silicone oil
8. 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
9. Central corneal thickness that is less than 450 microns or greater than 620 microns
10. Previous cilioablative procedure
11. Neovascular glaucoma
12. Uveitic Glaucoma
13. Pseudoexfoliative or pigmentary glaucoma
14. Chronic inflammation
15. Previous incisional ophthalmic surgery within 6 months prior to study
16. 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
17. 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
Study locations
- AKH Wien, Vienna, Austria
- Glaucoma Clinic, UZ Leuven, Leuven, Belgium
- Internationale Innovative Opthalmochirurgie GbR, Düsseldorf, Germany
- Universitätsklinikum Tübingen, Department für Augenheilkunde, Tübingen, Germany
- Irccs Fondazione G. B. Bietti, Rome, Italy
- Ospedale di Sassuolo, Sassuolo, Italy
- Policlinico Universitario Molinette, Turin, Italy
- Universiteitskliniek voor Oogheelkunde Maastricht, Maastricht, Netherlands
- ULS Santa Maria, Lisboa, Lisbon, Portugal
- Hospital Clinico San Carlos, San Carlos, Spain
Showing 10 of 12 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-06.