PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
ConditionPrimary Open Angle Glaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorSanten SAS
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Microshunt XI
Treatment groups
112 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov