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

Study Overview
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Brief Summary
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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.

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

Conditions
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This Study is Conducted Under Inclusion/ Exclusion Criteria

Intervention / Treatment
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* Device: MIMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥ 18 years to ≤ 85 years old Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye Manifest 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 eye Shaffer grade ≥ III in all four angle quadrants in the study eye Subject is treated with 0 to 5 hypotensive medications in the study eye Subject is able and willing to attend all scheduled follow-up exams Subject understands and signs the informed consent In 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 glaucoma Exclusion Criteria: - Exclusion Criteria Subjects 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 eye Closed 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 eye Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye Subject 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 measurements Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye History of idiopathic or autoimmune uveitis in either eye Severe trauma in study eye Active 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 period Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye Aphakia Prior vitreoretinal surgery in study eye Clinically significant ocular inflammation or infection within 90 days prior to screening Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions Uncontrolled 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 visits Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit Pregnant or lactating women Additionally, 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 eye Prior cilioablative procedure in the study eye

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm 1<br>Eyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), where IOP is not controlled when using maximum tolerated glaucoma medications | Device: MIMS<br>* 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.<br>|
| Experimental: Treatment Arm 2<br>Eyes of subjects with uncontrolled (IOP > 20 mmHg) open-angle glaucoma (OAG), who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications [Treatment Arm 2 and Treatment Arm 3]. | Device: MIMS<br>* 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.<br>|
| Experimental: Treatment Arm 3<br>Two (2) inferonasal sclerostomies will be performed by the MIMS® system in the eyes of subjects who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications (i.e., refractory glaucoma). | Device: MIMS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications at 24-week visit | • Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications. Subjects who will undergo reoperation for glaucoma prior to the 24 weeks visit will be considered failures in the analysis. | 24 weeks |