Overview

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

Eligibility

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