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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

RecruitingN/A

Sponsor: Santen SAS

Conditions: Primary Open Angle Glaucoma

Interventions: Microshunt XI

Countries: Austria, Belgium, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (11)

Vienna, Austria
Leuven, Belgium
Düsseldorf, Germany
Tübingen, Germany
Rome, Italy
Turin, Italy
Maastricht, Netherlands
Lisbon, Portugal
San Carlos, Spain
London, United Kingdom
London, United Kingdom