Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

Not Applicable

Terminated

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

• Registration Number: NCT03736655
• Lead Sponsor: Ciliatech

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a 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

68 patients will be included in this 5 years 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 an interposition supraciliary permanent device.

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 First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2019-03-15
• Primary Completion: 2021-04-01
• Study Completion: 2021-10-25
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-03
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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
• Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, ...)
• Medical treatment having intraocular hypotensive effect

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

Trial Locations

Locations (1)

Hopital Paris Saint Joseph; 🇫🇷 Paris, France