An observational study in Primary Open Angle Glaucoma, sponsored by Santen SAS. Recruiting at 12 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Santen SAS (part of Santen Pharmaceutical Co., Ltd.) · Observational
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.
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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 112 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Santen SAS is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
First submitted after Santen Inc. became part of Santen Pharmaceutical Co., Ltd..
Counted across the registry records on this site, refreshed daily.
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;
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Intervention Model/Device: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival/Tenon implantation.
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
Time frame: Screening to 12 months
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
Time frame: At 12 months
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
Time frame: Screening to 12 months
Not enrolling at this site.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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