PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

Prior treatment

• 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

Other illness

• 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

Other

• 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

• 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