NCT05159817Active, not recruitingNot Applicable
Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ciliatech
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Assess post-op IOP reduction
Study 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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