New eye implant aims to ease glaucoma pressure

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria To be included in the study, all patients must meet all the following inclusion criteria: Patient: 1. 18 years or older 2. Able to understand study requirements 3. Able and willing: 1. To provide written consent on the EC-approved Informed Consent Form, 2. To comply with all study requirements, including required study follow-up visits' agenda Eye: 4. Glaucoma (angle from 1 to 4 according to Schaffer grade), including pseudo exfoliative and pigmentary glaucoma, which meets the following: 1. Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p\<5% level as defined by the instrument's built-in age-adjusted normative database, 2. Glaucoma visual field with -15 \< MD \< 0dB (Humphrey) or 0 \< MD \< 15 dB (Octopus) 5. Pharmacological treatments: glaucoma not adequately controlled by 1 to 3 different IOP-lowering medication(s), given each for at least one month prior to Screening, 6. IOP: 1. if using 1 or 2 IOP-lowering medications, IOP is between 18 mmHg and 30 mmHg in the study eye at Screening visit 2. if using 3 IOP-lowering medications, IOP is between 18 mmHg and 25 mmHg in the study eye at Screening visit 7. Having the indication for glaucoma surgery alone (no concomitant cataract surgery) 8. Central Corneal Thickness between 480 to 620 µm 9. Gonioscopy confirming normal angle anatomy at site of implantation. Angle anatomy may include Peripheral Anterior Synechiae (PAS) of up to maximum of 3 clock hours if not present parallel to the proposed site of device implantation. Exclusion criteria Patients will not participate in this clinical study if they meet any of the following criteria: Patient: 1. Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder 2. Patient already included in another study 3. A person protected by law (temporary or permanent guardianship) or not capable of discernment 4. Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …) 5. Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening) 6. With 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 (e.g. inability to reliably complete visual field testing over the course of the study, or take glaucoma medications (e.g. Parkinson's disease), or uncontrolled systemic disease (diabetes, hypertension) that could compromise participation in the study, …) 7. Who have a new or modified prescription for a systemic treatment that could influence IOP within one month prior to inclusion, or who are aware of a future change in their systemic treatment, or if their medical condition indicates that their systemic treatment may change in the future 8. Chemotherapy in the last 6 months before surgery Eye: 9. Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome) 10. Fast progressing or very severe glaucoma or any condition requiring a filtering surgery 11. History of any incisional glaucoma surgery or implantable glaucoma device 12. Prior SLT, ALT or MLT 13. Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma 14. Eye with uncontrolled IOP despite 4 IOP-lowering medications prescribed for more than a month 15. Eye with severe OSD and / or severe dry eye defined as Oxford score ≥ 4 16. Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology) 17. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge Weber syndrome, orbital tumors, orbital congestive disease 18. Any known ocular condition that may require intraocular intervention during the protocol required follow-up period 19. Premature or mature cataract (initial cataract are accepted) 20. Any condition that prevents the investigational device implantation in the superior and nasal region of the eye 21. Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications 22. Non laser retinal surgery 23. Previous cyclodestructive or scleral buckling procedure 24. History of complicated cataract surgery (as posterior capsular rupture, vitreous loss) 25. History of silicone oil 26. Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery 27. Use of oral hypotensive glaucoma medications for treatment of the fellow eye 28. Axial length \<20 mm 29. Severe myopia defined as spherical correction \< -8 Diopters 30. Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye 31. Peripheral synechia at the angle 32. Closed angle 33. Peripheral laser iridotomy in the last 7 days before planned surgery 34. Epithelial or fibrous downgrowth 35. Any kind of endothelial dystrophy 36. Severe blepharitis 37. Chronic or recurrent uveitis 38. Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation 39. Active iris neovascularization, rubeosis, proliferative retinopathy, diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders), vitreous haemorrhage, preretinal haemorrhage, choroidopathy or other ophthalmic disease that could confound study results 40. Scleral fixation IOL 41. Lens dislocation or subluxation 42. Vitreous loss in the anterior chamber