Glaucoma, Open-Angle
Conditions
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.
Interventions
Surgical placement of an interposition supraciliary implant in the supraciliary space
Sponsors
Ciliatech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed