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

Not Applicable

Not yet recruiting

• Conditions: Glaucoma, Narrow Angle; Glaucoma, Open-Angle
• Interventions: Device: Cilioscleral Interposition Device

• Registration Number: NCT05625958
• Lead Sponsor: Ciliatech

Brief 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

35 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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14
• Study Start: 2023-03-01
• Primary Completion: 2023-10-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Diagnosis of POAG Schafer 1 to 4
• Medicated IOP ≥ 21
• naive of any prior glaucoma surgery

Exclusion Criteria

• Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cilioscleral Interposition Device	Cilioscleral Interposition Device	Any patients corresponding to inclusion / exclusion criteria

Primary Outcome Measures

Name	Time	Method
Assess post-op IOP reduction	6 months	Proportion of eyes with \>= 20% decrease in mean-Diurnal-IOP from baseline