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

Launched by SANOCULIS LTD · Nov 27, 2022

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ≥ 18 years to ≤ 85 years old
• • 2. Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye
• • 3. 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)
• • 4. Optic nerve appearance characteristic of glaucoma in the study eye
• • 5. Shaffer grade ≥ III in all four angle quadrants in the study eye
• • 6. Subject is treated with 0 to 5 hypotensive medications in the study eye
• • 7. Subject is able and willing to attend all scheduled follow-up exams
• • 8. 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:
• 9. 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:
• • 1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
• • 2. 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)
• • 3. Congenital or developmental glaucoma in either eye
• • 4. Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye
• • 5. Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
• • 6. Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
• • 7. Subject has history of penetrating keratoplasty (PKP)
• • 8. 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
• • 9. Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye
• • 10. Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye
• • 11. History of idiopathic or autoimmune uveitis in either eye
• • 12. Severe trauma in study eye
• • 13. 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
• • 14. Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye
• • 15. Aphakia
• • 16. Prior vitreoretinal surgery in study eye
• • 17. Clinically significant ocular inflammation or infection within 90 days prior to screening
• • 18. Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions
• • 19. 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
• • 20. Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
• • 21. 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:
• • 22. Prior glaucoma filtering surgery, such as trabeculectomy, in the study eye
• • 23. Prior cilioablative procedure in the study eye