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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05159817

Acronym

SAFARI FU

Enrollment

Registered

2021-12-16

Start date

2021-12-15

Completion date

2024-12-31

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assess post-op IOP reduction	12, 24 and 36 months	Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%

Countries

Armenia

Outcome results