Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)

Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery

The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

22 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 novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices.

Several patient data like 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:

Patient:

1. Patient ≥ 50 years old

2. Patient dated and signed the informed consent form to participate in the study at first visit

   Eye:

3. Phakic, pseudophakic or aphakic eye

4. Has medically treated open-angle glaucoma (schaffer grade 3 and 4)

5. The optimal medical treatment against glaucoma for this eye has failed i. Preoperative treatment ≥ 2 molecules with target IOP not reached despite medication, ii. or IOP ≥ 21 mmHg under treatment, iii. or patient not compliant with treatment, iv. or patient intolerant to treatment

6. Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months.

7. Having the indication for glaucoma surgery alone

Exclusion criteria

Patient:

1. Patient with visual acuity of the contralateral eye greater than LogMar 0.3. If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7

2. Patient with a known allergy to any of the constituents of the products used in this study

3. Patient already included in another study

4. A person protected by law (temporary or permanent guardianship) or not capable of discernment

   Eye

5. Presenting with inflammatory glaucoma

6. Presenting with congenital glaucoma

7. Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)

8. Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.)

9. Having had eye surgery (other than glaucoma) less than 6 months ago

10. Closed angle, grade 1 or 2 Schafer OAG

11. Pre-existing ocular or systemic pathology that may cause post operative complications such as:

    • Clinically significant inflammation such as uveitis
    • Eye infection
    • Anterior segment neovascular disease

12. Severe dry eye syndrome

13. Severe blepharitis

14. Retinopathy which can lead to neovascular complications in the anterior segment

15. Eye of axial length <20 mm

16. Eye with lens dislocation or subluxation