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

Glaucoma, Open-Angle Clinical Trial

Official title:
Non Randomised Mono-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 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

Clinical Trial Description

20 patients will be included in this 6 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04770324
Study type Interventional
Source Ciliatech
Contact
Status Active, not recruiting
Phase N/A
Start date February 15, 2021
Completion date March 31, 2024
View Details
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