NCT05236439

Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma and Narrow Angle Glaucoma

Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of Supraflow v2.2 in Glaucoma Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Ciliatech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Glaucoma, Open-Angle
• Glaucoma, Narrow Angle

Interventions

Type	Name	Description
DEVICE	Interposition supraciliary implant	Surgical placement of SV22 interposition supraciliary implant in the supraciliary space

Timeline

• Start date: 2022-05-23
• Primary completion: 2025-02-19
• Completion: 2025-12-15
• First posted: 2022-02-11
• Last updated: 2025-10-01

Locations

1 site across 1 country: Armenia