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NCT05625958 Clinical Trial

Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

Glaucoma, Open-Angle Clinical Trial

— SAFARI4  

Official title:
Multicentre, Non-randomised Clinical Study Evaluating the Efficacy and Safety of Cilioscleral Interposition Device v2.2 in Glaucoma Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05625958
Other study ID # SAFARI 4
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date June 1, 2026

Study information
Verified date November 2022
Source Ciliatech
Contact Olivier BENOIT
Phone +33635550153
Email o.benoit@cilia.tech
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 a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

Description:

35 patients will be included in this 36 months interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device. Several patient data like safety events, 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 Not yet recruiting
Enrollment 35
Est. completion date June 1, 2026
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of POAG Schafer 1 to 4 - Medicated IOP = 21 - naive of any prior glaucoma surgery Exclusion Criteria: - Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cilioscleral Interposition Device
Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ciliatech

Outcome
Type Measure Description Time frame Safety issue
Primary Assess post-op IOP reduction Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline 6 months
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