Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Ciliatech
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Assess post-op IOP reduction
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of implanting 2 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
22 patients will be included in this 36 months 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 2 interposition supraciliary permanent devices. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assess post-op IOP reduction
Time Frame: 6, 12, 24, 26, 48, 60 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success
Time Frame: 6, 12, 24, 26, 48, 60 months
Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg
Secondary Outcomes
- assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold(Up to 60 months)
- assess the rate of patients with no filtering bleb(Up to 60 months)
- Average number of adjunctive therapies and follow up visits(Up to 60 months)
- Evaluate surgical procedure(Day 0, day of surgery)
- Evaluate implant and surgical procedure safety(up to 60 months)
- Compare clinical success rate(Up to 60 months)
- assess rate of patients with a reduction in post-op IOP with or without combined treatments(Up to 60 months)
- assess the mean and median reduction in IOP(Up to 60 months)
- assess the rate of patients without medical treatment for glaucoma(Up to 60 months)
- average rate of IOP reduction(Up to 60 months)
- assess the rate of patients with a reduction of IOP post-operatively(Up to 60 months)
- assess IOP stability(Up to 60 months)
- Assess patient satisfaction(Up to 60 months)
- Assess changes in quality of life(Up to 60 months)
- Follow the progression of glaucoma and potential complications(Up to 60 months)