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

Ciliatech

Status

Terminated

Conditions

Glaucoma, Open-Angle

Treatments

Device: Interposition supraciliary implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT03736655

CIV-FR-18-07-024848

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

50 to 99 years old

Volunteers

No Healthy Volunteers

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