PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: Microshunt XI

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 Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

• Study Contact: Name: Study Director / Medical Monitor Raymund Angeles; Phone Number: 510-368-9861; Email: raymund.angeles@santen.com
• Study Contact Backup: Name: Santen SAS Clinical Operations; Email: bianca.groenendijk@santen.com

Study Locations

• Austria
  • Vienna, Austria
    • Not yet recruiting
    • AKH Wien
    • Contact: Prof. Clemens Vass
• Belgium
  • Leuven, Belgium
    • Not yet recruiting
    • Glaucoma Clinic, UZ Leuven
    • Contact: Prof. Ingeborg Stalmans
• Germany
  • Düsseldorf, Germany
    • Not yet recruiting
    • Internationale Innovative Opthalmochirurgie GbR
    • Contact: Dr Karsten Klabe
  • Tübingen, Germany
    • Not yet recruiting
    • Universitätsklinikum Tübingen, Department für Augenheilkunde
    • Contact: Prof. Bogomil Voykov
• Italy
  • Rome, Italy
    • Not yet recruiting
    • Irccs Fondazione G. B. Bietti
    • Contact: Dr Francesco Oddone
  • Turin, Italy
    • Not yet recruiting
    • Policlinico Universitario Molinette
    • Contact: Prof. Antonio Fea
• Netherlands
  • Maastricht, Netherlands
    • Not yet recruiting
    • Universiteitskliniek voor Oogheelkunde Maastricht
    • Contact: Prof. Henny Beckers
• Portugal
  • Lisbon, Portugal
    • Not yet recruiting
    • ULS Santa Maria, Lisboa
    • Contact: Prof. Luis Abegao Pinto
• Spain
  • San Carlos, Spain
    • Not yet recruiting
    • Hospital Clinico San Carlos
    • Contact: Prof. Julián García-Feijóo
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Moorfields Eye Hospital NHS Foundation Trust
    • Contact: Prof. Gus Gazzard
  • London, United Kingdom
    • Recruiting
    • Guy's and St. Thomas' NHS Foundation Trust
    • Contact: Prof. Kin Sheng Lim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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;

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Microshunt XI; The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device; Other Names: Intervention Model/Device: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival/Tenon implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Screening to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Outcome Incidence of all device- and/or procedure-related adverse events	This is a primary safety outcome for Incidence of all device- and/or procedure-related adverse events during the study	Screening to 12 months

Collaborators and Investigators

• Sponsor: Santen SAS

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: POAG
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 200011001SW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No