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
This trial does not accept healthy volunteersQualifiers
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 population
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;
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Microshunt XI
DeviceThe PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device
Treatment groups
112 Participants
are divided into 1 treatment groupGroup A: Microshunt XI treatment group1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 monthsOther outcomes
1
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 Source ClinicalTrials.gov