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Follow-up of the PRESERFLO MicroShunt XI eye implant in open angle glaucoma

Follows adults with primary open angle glaucoma who receive the MicroShunt XI implant.

Key facts

Who runs it
Santen SAS
Where
London, United KingdomSee the 2 sitesAlso in 7 other countries, 10 sites
Trial code
Registry title
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Status
Recruiting
People taking part
112 people, planned
Started
19 Mar 2026
Expected to end
Sept 2027
Type of study
Observational
Treatments tested
  • Microshunt XI
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary open angle glaucoma whose eye pressure is not well controlled on the most medicine they can tolerate, and who are having an eye pressure-lowering implant (PRESERFLO MicroShunt XI).

Age
18 to 85 years
Sex
Women and men can join.
Disease stage
Primary open angle glaucoma. Eye pressure not controlled on maximum tolerated medicine. Eye pressure of 18 mmHg to 35 mmHg while on glaucoma medicines.
Earlier treatment
Must have been on the most glaucoma medicine they can tolerate. Cannot have had eye surgery with a cut (incisional) within 6 months before the study, or a previous cilioablative procedure.

Main reasons for not taking part

  • Angle closure, neovascular, uveitic, pseudoexfoliative or pigmentary glaucoma
  • Scarring of the conjunctiva or earlier eye surgery involving the conjunctiva
  • Active eye inflammation, such as conjunctivitis, scleritis, keratitis or uveitis
  • Glaucoma surgery planned together with another eye procedure, such as cataract surgery
  • Central corneal thickness under 450 microns or over 620 microns

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in United Kingdom

Also in 7 other countries, 10 sites

  • Guy's and St Thomas' NHS Foundation TrustLondon, United KingdomContact: Prof. Kin Sheng LimTaking people
  • Moorfields Eye Hospital NHS Foundation TrustLondon, United KingdomContact: Prof. Gus GazzardTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • 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.

    Treatment: Microshunt XI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma
Plain-language title
Follow-up of the PRESERFLO MicroShunt XI eye implant in open angle glaucomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07235592, who can take part
Record updated
28 October 2026