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NCT04770324 Clinical Trial

Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)

Glaucoma, Open-Angle Clinical Trial

— SAFARI 2  

Official title:
Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04770324
Other study ID # SAFARI 2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date March 31, 2024

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

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Description:

20 patients will be included in this 6 months interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices. Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 22
Est. completion date March 31, 2024
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Diagnosis of POAG Schafer 3 or 4 - Medicated IOP = 21 Exclusion Criteria: - Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Interposition supraciliary implant
Surgical placement of 2 interposition supraciliary implant in the supraciliary space

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% 6 months
Primary Assess post-op IOP clinical success Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg 6 months
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