NCT05159817
Active, not recruiting
Not Applicable
Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery
ConditionsGlaucoma, Open-Angle
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Ciliatech
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Assess post-op IOP reduction
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.
Detailed Description
19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted. These patients reached 6 months follow-up and the original study had to be interrupted. This observational study prolonges follow-up to 36 months
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
Exclusion Criteria
- •if cannot assist to all future follow-up visits
Outcomes
Primary Outcomes
Assess post-op IOP reduction
Time Frame: 12, 24 and 36 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Study Sites (1)
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