PRESERFLO MicroShunt XI: patient experience follow-up after implantation for open-angle glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, post-market observational study evaluating the safety and performance of the PRESERFLO MicroShunt XI in adults with primary open angle glaucoma. Participants have IOP between 18 and 35 mmHg despite maximum tolerated medical therapy or progression warranting surgery, and receive the MicroShunt XI without a control group. The study tracks device-related outcomes, including intraocular pressure changes and any safety events, over time in routine clinical settings. Ophthalmologists trained in the device perform the implantation, and no biospecimens or comparative interventions are involved. The trial helps gather real-world data on how the device behaves outside the initial approval context.

Why it matters

Who can join: the full rules

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

Where it's running

• AKH Wien
  Vienna, Austria Recruiting
• Glaucoma Clinic, UZ Leuven
  Leuven, Belgium Recruiting
• Internationale Innovative Opthalmochirurgie GbR
  Düsseldorf, Germany Recruiting
• Universitätsklinikum Tübingen, Department für Augenheilkunde
  Tübingen, Germany Recruiting
• Irccs Fondazione G. B. Bietti
  Rome, Italy Recruiting
• Universiteitskliniek voor Oogheelkunde Maastricht
  Maastricht, Netherlands Recruiting

Study contacts

• Study coordinator: Study Director / Medical Monitor Raymund Angeles
• Email: raymund.angeles@santen.com
• Phone: 510-368-9861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.