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Recruiting NCT07235592

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

— Observational Primary Open Angle Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microshunt XI.
Who it may be relevant to
Registry conditions: Primary Open Angle Glaucoma. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, Germany, Italy, Netherlands +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Microshunt XI
    The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Primary outcome measures

  • Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure [Time frame: Screening to 12 months]
Secondary outcome measures (1)
  • Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure [Time frame: At 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 2 centers
  • Internationale Innovative Opthalmochirurgie GbR — Düsseldorf
  • Universitätsklinikum Tübingen, Department für Augenheilkunde — Tübingen
Italy · 2 centers
  • Irccs Fondazione G. B. Bietti — Rome
  • Policlinico Universitario Molinette — Turin
United Kingdom · 2 centers
  • Guy's and St. Thomas' NHS Foundation Trust — London
  • Moorfields Eye Hospital NHS Foundation Trust — London
Austria · 1 center
  • AKH Wien — Vienna
Belgium · 1 center
  • Glaucoma Clinic, UZ Leuven — Leuven
Netherlands · 1 center
  • Universiteitskliniek voor Oogheelkunde Maastricht — Maastricht
Portugal · 1 center
  • ULS Santa Maria, Lisboa — Lisbon
Spain · 1 center
  • Hospital Clinico San Carlos — San Carlos

Identifiers

NCT: NCT07235592 · 200011001SW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗