NCT05625958

Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

Multicentre, Non-randomised Clinical Study Evaluating the Safety and Efficacy of a Cilioscleral Interposition Device ("CID") v2.2 in Glaucoma Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• 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 and narrow angle glaucoma who have failed at least one class of topical medical therapy

Detailed description

29 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	Cilioscleral Interposition Device	Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

Timeline

• Start date: 2023-03-23
• Primary completion: 2026-03-01
• Completion: 2028-09-01
• First posted: 2022-11-23
• Last updated: 2025-10-01

Locations

6 sites across 1 country: Spain