PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

NCT ID: NCT07235592

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-04-30

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.

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.

Conditions

Primary Open Angle Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Microshunt XI

Intervention Type: DEVICE

The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Interventions

Microshunt XI

The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Intervention Type: DEVICE

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santen SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AKH Wien

Vienna, , Austria

Glaucoma Clinic, UZ Leuven

Leuven, , Belgium

Internationale Innovative Opthalmochirurgie GbR

Düsseldorf, , Germany

Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, , Germany

Irccs Fondazione G. B. Bietti

Rome, , Italy

Policlinico Universitario Molinette

Turin, , Italy

Universiteitskliniek voor Oogheelkunde Maastricht

Maastricht, , Netherlands

ULS Santa Maria, Lisboa

Lisbon, , Portugal

Hospital Clinico San Carlos

San Carlos, , Spain

Guy's and St. Thomas' NHS Foundation Trust

London, , United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Countries

Austria; Belgium; Germany; Italy; Netherlands; Portugal; Spain; United Kingdom

Central Contacts

Study Director / Medical Monitor Raymund Angeles

Role: CONTACT

raymund.angeles@santen.com

510-368-9861

Santen SAS Clinical Operations

Role: CONTACT

bianca.groenendijk@santen.com

Facility Contacts

Prof. Clemens Vass

Role: primary

Prof. Ingeborg Stalmans

Role: primary

Dr Karsten Klabe

Role: primary

Prof. Bogomil Voykov

Role: primary

Dr Francesco Oddone

Role: primary

Prof. Antonio Fea

Role: primary

Prof. Henny Beckers

Role: primary

Prof. Luis Abegao Pinto

Role: primary

Prof. Julián García-Feijóo

Role: primary

Prof. Kin Sheng Lim

Role: primary

Prof. Gus Gazzard

Role: primary

Other Identifiers

200011001SW

Identifier Type: -

Identifier Source: org_study_id