SAFARI4: Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
35 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cilioscleral Interposition Device Any patients corresponding to inclusion / exclusion criteria |
Device: Cilioscleral Interposition Device
Surgical placement of SV22 cilioscleral interposition device in the supraciliary space
|
Outcome Measures
Primary Outcome Measures
- Assess post-op IOP reduction [12 months]
Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of POAG Schafer 1 to 4
-
Medicated IOP ≥ 21
Exclusion Criteria:
-
Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
-
naive of any prior glaucoma surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ciliatech
Investigators
- Principal Investigator: Julian GARCIA FEIJOO, Pr, Clinica San Carlos
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAFARI 4