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NCT05159817 Clinical Trial

Study of an Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

Glaucoma, Open-Angle Clinical Trial

— SAFARI FU  

Official title:
Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05159817
Other study ID # SAFARI FU
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date December 31, 2024

Study information
Verified date February 2023
Source Ciliatech
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 19
Est. completion date December 31, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Armenia Malayan Center Yerevan

Sponsors (1)
Lead Sponsor Collaborator
Ciliatech

Country where clinical trial is conducted

Armenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess post-op IOP reduction Proportion of Eyes With Intraocular Pressure (IOP) Reduction of = 20% 12, 24 and 36 months
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