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Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma — SAFARI 3  

Glaucoma, Open-Angle Clinical Trial

Official title:
Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Cilioscleral Interposition Device (CID) SV22 in Glaucoma Patients Refractory to Topical Therapy

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05236439
Study type Interventional
Source Ciliatech
Contact
Status Active, not recruiting
Phase N/A
Start date May 1, 2022
Completion date March 31, 2026
View Details
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