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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04770324
• Lead Sponsor: Ciliatech

Brief 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

20 patients will be included in this 6 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.

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Primary Completion: 2021-11-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Diagnosis of POAG Schafer 3 or 4
• Medicated IOP ≥ 21

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 Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success	6 months	Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg

Trial Locations

Locations (1)

Malayan Center; 🇦🇲 Yerevan, Armenia