Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure - Performance Evaluation Study

Minimally Invasive Micro Sclerostomy (MIMS®) device is intended for the reduction of elevated Intraocular Pressure (IOP).MIMS® is a powered surgical device, designed to create a drainage channel of 100 microns diameter at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjunctival space), at the inferonasal quadrant of the eye (i.e., inferonasal sclerostomy).The drainage channel is created by a sterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch.

Inclusion Criteria:Male or female ≥ 18 years to ≤ 85 years oldUnsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eyeManifest open angle glaucoma (OAG) with typical disc or visual field changes and open iridocorneal angle in the study eye (in accordance with European Glaucoma Society (EGS) criteria 1)Optic nerve appearance characteristic of glaucoma in the study eyeShaffer grade ≥ III in all four angle quadrants in the study eyeSubject is treated with 0 to 5 hypotensive medications in the study eyeSubject is able and willing to attend all scheduled follow-up examsSubject understands and signs the informed consentIn addition, subjects meeting the following criterion will be considered for enrolment into Treatment Arm 2 or Treatment Arm 3 of the trial:Subject with refractory glaucoma, defined as prior failure of filtering procedure and/or uncontrolled IOP on maximally tolerated medical therapy (i.e., ≥ 4 classes of topical IOP-lowering medications, or fewer in the case of tolerability or efficacy issues) . Specifically, subjects who:Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery);Have neovascular glaucoma;Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucomaExclusion Criteria:- Exclusion CriteriaSubjects presenting 1 or more of the following criteria will not be enrolled in any of the treatment arms of the trial:Ocular conditions with a poorer prognosis in the fellow eye than in the study eyeClosed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy System procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL)Congenital or developmental glaucoma in either eyeFixation threatening visual-field defects or IOP ≥40 mmHg in the study eyeOther secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eyePeripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eyeSubject has history of penetrating keratoplasty (PKP)Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurementsPrior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eyeBest-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eyeHistory of idiopathic or autoimmune uveitis in either eyeSevere trauma in study eyeActive iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month periodVitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eyeAphakiaPrior vitreoretinal surgery in study eyeClinically significant ocular inflammation or infection within 90 days prior to screeningUnable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructionsUncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visitsCurrent participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visitPregnant or lactating womenAdditionally, subjects presenting 1 or more of the following criteria will not be enrolled in Treatment Arm 1 of the trial:Prior glaucoma filtering surgery, such as trabeculectomy, in the study eyePrior cilioablative procedure in the study eye