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

Active, not recruiting

• Conditions: Glaucoma, Open-Angle

• Registration Number: NCT05159817
• Lead Sponsor: Ciliatech

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 Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study Start: 2021-12-15
• Study First Posted: 2021-12-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13
• Primary Completion: 2024-02-28
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Malayan Center; 🇦🇲 Yerevan, Armenia