Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma and Narrow Angle Glaucoma

Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of Supraflow v2.2 in Glaucoma Surgery

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 angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy

57 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

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:

   To provide written consent on the EC-approved Informed Consent Form, b. To comply with all study requirements, including required study follow-up visits' agenda

   Eye:

4. Primary Open Angle Glaucoma (POAG) or Narrow Angle Glaucoma (PNAG), 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 (Humphrey) with -15 < MD < 0dB

5. Pharmacological treatments: glaucoma not adequately controlled by 1 to 4 different IOP-lowering medication(s), given each for at least one month prior to Screening,

6. IOP: if using 1 to 4 IOP-lowering medication, IOP is between 21 mmHg and 35 mmHg in the study eye at Screening and Baseline visits

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

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. History of any incisional glaucoma surgery or implantable glaucoma device

11. Prior SLT, ALT or MLT

12. Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma

13. Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology)

14. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease

15. Any known ocular condition that may require intraocular intervention during the protocol required follow-up period

16. Premature or mature cataract (initial cataract are accepted)

17. Any condition that prevents the investigational device implantation in the superior and nasal region of the eye

18. Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications

19. Non laser retinal surgery

20. Previous cyclodestructive or scleral buckling procedure

21. History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)

22. History of silicone oil

23. Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery

24. Use of oral hypotensive glaucoma medications for treatment of the fellow eye

25. Axial length <20 mm

26. Severe myopia

27. Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye

28. Peripheral synechia at the angle

29. Closed angle

30. Peripheral laser iridotomy in the last 7 days before planned surgery

31. Epithelial or fibrous downgrowth

32. Severe dry eye syndrome

33. Severe blepharitis

34. Chronic or recurrent uveitis

35. Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation

36. 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

37. Scleral fixation IOL

38. Lens dislocation or subluxation

39. Vitreous loss in the anterior chamber