PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

NCT07235592 | Not Yet Recruiting

• 1 other identifier: 200011001SW
• Study Type: observational
• Target: 112
• Locations: 8 countries
• Sites: 11

Brief Summary

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.

Conditions

Primary Open Angle Glaucoma

Keywords

POAG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure

  At 12 months

Other Outcomes (1)

• Primary Safety Outcome Incidence of all device- and/or procedure-related adverse events

  Screening to 12 months

Study Arms (1)

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

Interventions

Microshunt XI DEVICE

The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Also known as: Intervention Model/Device: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival/Tenon implantation.

Microshunt XI treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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

You may not qualify if:

• Angle closure glaucoma
• Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)
• 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
• 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
• Central corneal thickness that is less than 450 microns or greater than 620 microns
• Previous cilioablative procedure
• Neovascular glaucoma
• Uveitic Glaucoma
• Pseudoexfoliative or pigmentary glaucoma
• Chronic inflammation
• Previous incisional ophthalmic surgery within 6 months prior to study

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (11)

AKH Wien

Vienna, Austria

Location

Glaucoma Clinic, UZ Leuven

Leuven, Belgium

Location

Internationale Innovative Opthalmochirurgie GbR

Düsseldorf, Germany

Location

Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, Germany

Location

Irccs Fondazione G. B. Bietti

Rome, Italy

Location

Policlinico Universitario Molinette

Turin, Italy

Location

Universiteitskliniek voor Oogheelkunde Maastricht

Maastricht, Netherlands

Location

ULS Santa Maria, Lisboa

Lisbon, Portugal

Location

Hospital Clinico San Carlos

San Carlos, Spain

Location

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Study Director / Medical Monitor Raymund Angeles

CONTACT

510-368-9861; raymund.angeles@santen.com

Santen SAS Clinical Operations

CONTACT

bianca.groenendijk@santen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

DE (2); NL (1); GB (2); PT (1); AU (1); ES (1); BE (1); IT (2)