Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study

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 thestudy eye (in accordance with European Glaucoma Society (EGS) criteria 1) 4. Opticnerve appearance characteristic of glaucoma in the study eye 5. Shaffer grade ≥ III inall four angle quadrants in the study eye 6. Subject is treated with 0 to 5hypotensive medications in the study eye 7. Subject is able and willing to attend allscheduled follow-up exams 8. Subject understands and signs the informed consent

Exclusion Criteria:

• 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 surgeryimmediately prior to the Minimally Invasive Nasal Trabeculostomy procedure or thestudy eye is pseudophakic with posterior chamber intraocular lens (PCIOL) 3.Congenital or developmental glaucoma in either eye 4. Fixation threateningvisual-field defects or IOP ≥40 mmHg in the study eye
3. Other secondary glaucoma (such as neovascular, uveitic, lens-induced,trauma-induced, or glaucoma associated with increased episcleral venous pressure)in the study eye
4. Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in thestudy eye
5. Subject has history of penetrating keratoplasty (PKP)
6. Any previous surgery in the study eye (at the access site of the MinimallyInvasive Nasal Trabeculostomy System application), where the conjunctiva is notintact and elastic (except for clear corneal cataract surgery)
7. Any ocular disease or history in study eye such as severe dry eye, activeproliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, andocular pathology that may interfere with accurate IOP measurements
8. Prior surgery for an ab-interno or ab-externo device implanted in or through theSchlemm's canal in the study eye.
9. Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the felloweye
10. History of idiopathic or autoimmune uveitis in either eye
11. Severe trauma in study eye
12. Active iris neovascularization, previous cyclodestructive procedure, priorscleral buckling procedure, presence of silicone oil, need for glaucoma surgerycombined with other ocular procedures or anticipated need for additional ocularsurgery in study eye within 12 month period
13. Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage instudy eye
14. Aphakia
15. Prior vitreoretinal surgery in study eye
16. Clinically significant ocular inflammation or infection within 90 days prior toscreening
17. Unable to discontinue use of blood thinners in accordance with surgeon's standardpreoperative instructions
18. Uncontrolled systemic disease that in the opinion of the investigator would putthe subject's health at risk and/or prevent the subject from completing all studyvisits
19. Current participation or participation in another investigational drug or deviceclinical trial within the last 30 days before screening visit
20. Pregnant or lactating women