Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Ciliatech
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Assess post-op IOP clinical success
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Assess post-op IOP clinical success
Time Frame: 6 months
Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg
Assess post-op IOP reduction
Time Frame: 6 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Secondary Outcomes
No secondary outcomes reported