Follow-up of the PRESERFLO MicroShunt XI eye implant in open angle glaucoma
Follows adults with primary open angle glaucoma who receive the MicroShunt XI implant.
Plain-language title generated from the registry record
Registry title: PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Key facts
- Where
- Düsseldorf and Tübingen, GermanySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07235592, who can take part
Where in Germany
- Internationale Innovative Opthalmochirurgie GbRDüsseldorf, GermanyTaking people
- Universitätsklinikum Tübingen, Department für AugenheilkundeTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Santen SAS
- Trial code
- NCT07235592
- Record updated
- 28 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium); 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; Previous cilioablative procedure; Previous incisional ophthalmic surgery within 6 months prior to study; 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; Angle closure glaucoma; 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); Intraocular silicone oil; Central corneal thickness that is less than 450 microns or greater than 620 microns; Neovascular glaucoma; Uveitic Glaucoma; Pseudoexfoliative or pigmentary glaucoma; Chronic inflammation; 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.