At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Microshunt XI (device)
- How long the study runs
- Study runs about 18 months (dates as stated)
- About the drug or intervention
- Microshunt XI — device: The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people with primary open angle glaucoma, a condition where pressure builds up inside the eye. It checks how the PRESERFLO™ MicroShunt XI device works when it is implanted, and there is no comparison group. The study is run by Santen SAS.
Who can take part
- Aged 18 to 85 years
- Diagnosed with primary open angle glaucoma where eye pressure is not well controlled on the strongest eye drops or medicines you can tolerate, with pressure between 18 and 35 mmHg while on glaucoma medication
- Willing to follow the study requirements
- Has signed an approved consent form
Who may not be able to
- Angle closure glaucoma
- Scarring or other problems with the conjunctiva (the clear tissue covering the eye), or previous eye surgery involving the conjunctiva
- Active new blood vessel growth on the iris (the coloured part of the eye)
- Active inflammation, such as blepharitis, conjunctivitis, scleritis, keratitis or uveitis
- Vitreous (gel from the back of the eye) in the front chamber of the eye
- An artificial lens placed in the front chamber of the eye
- Silicone oil in the eye
- Needing glaucoma surgery combined with other eye procedures (for example cataract surgery with lens implant), or likely to need other eye surgery during the study
- Central corneal thickness (thickness of the clear front of the eye) below 450 or above 620 microns
- Previous cilioablative procedure (treatment that destroys part of the eye's fluid-producing tissue)
- Neovascular glaucoma
- Uveitic glaucoma
- Pseudoexfoliative or pigmentary glaucoma
- Chronic (long-term) inflammation
- Eye surgery within 6 months before the study
- Taking part in this or another study (only one eye can take part in this study), or finished another study within 30 days of the screening check
- Any eye or health problem that, in the researcher's view, would raise the risk of complications, make the device unsafe to implant, or stop you following the study plan
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team (details of visits, tests and how long the study lasts are not given).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 112
- Started
- 2026-03-19
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for primary open angle glaucoma
- • Clinical study - 112 participants
- • 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
Who can take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with primary open angle glaucoma
Where?
- • London - Guy's and St. Thomas' NHS Foundation Trust
- • London - Moorfields Eye Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 85 Years
- Who can join: All genders
What the study is looking for
- ✓Male or female, age 18 to 85 years, inclusive
- ✓Patient willing to comply with study requirements
- ✓Patient who has signed an approved agreement to take part form
Who cannot take part
- ✗Angle closure glaucoma
- ✗Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival...
- ✗Active iris neovascularization
- ✗Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)
- ✗Vitreous in the anterior chamber
See the full criteria
Where Is This Study? (2 UK sites)
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom
Research Portfolio Managers- Daniela Narvaez, Anika Kadchha, Abi Chandrakumar, Xin Liu
moorfields.resadmin@nhs.net0207 566 2036How to Get in Touch
Study Director / Medical Monitor Raymund Angeles
Sponsor contactCONTACT
Santen SAS Clinical Operations
Sponsor contactCONTACT