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

Not Applicable

Active, not recruiting

• Conditions: Glaucoma, Open-Angle
• Interventions: Device: Interposition supraciliary implant

• Registration Number: NCT05236439
• 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 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.

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Study Start: 2022-05-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Diagnosis of Primary Glaucome Schafer 1 to 4
• Medicated IOP ≥ 21
• naive of any 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
Interposition supraciliary implant	Interposition supraciliary implant	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

Secondary Outcome Measures

Name	Time	Method
Compare efficacy outcomes between POAG and PNAG sub-groups	6 months	Absolute differences in IOP

Trial Locations

Locations (1)

Malayan center; 🇦🇲 Yerevan, Armenia