SAFARI: Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
68 patients will be included in this 5 years 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 an interposition supraciliary permanent device.
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Interposition supraciliary implant Any patients corresponding to inclusion / exclusion criteria |
Device: Interposition supraciliary implant
Surgical placement of an interposition supraciliary implant in the supraciliary space
|
Outcome Measures
Primary Outcome Measures
- Assess post-op IOP reduction [6 months]
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
- Assess post-op IOP clinical success [6 months]
Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of POAG Schafer 3 or 4
-
Medicated IOP ≥ 21
Exclusion Criteria:
-
Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
-
Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, …)
-
Medical treatment having intraocular hypotensive effect
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hopital Paris Saint Joseph | Paris | France | 75014 |
Sponsors and Collaborators
- Ciliatech
Investigators
- Study Director: Philippe SOURDILLE, Ciliatech
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIV-FR-18-07-024848