NCT04770324

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

Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ciliatech · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Detailed description

22 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 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.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DEVICE	Interposition supraciliary implant	Surgical placement of 2 interposition supraciliary implant in the supraciliary space

Timeline

• Start date: 2021-04-23
• Primary completion: 2024-07-26
• Completion: 2024-07-26
• First posted: 2021-02-25
• Last updated: 2025-10-01

Locations

1 site across 1 country: Armenia