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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Surgical placement of an interposition supraciliary implant in the supraciliary space
Hopital Paris Saint Joseph
Paris, France
Assess post-op IOP reduction
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Time frame: 6 months
Assess post-op IOP clinical success
Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg
Time frame: 6 months
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