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Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma — SAFARI  

Glaucoma, Open-Angle Clinical Trial

Official title:
Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03736655
Study type Interventional
Source Ciliatech
Contact
Status Terminated
Phase N/A
Start date March 15, 2019
Completion date October 25, 2021
View Details
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