Multicentre, Non-randomised Clinical Study Evaluating the Efficacy and Safety of Supraflow v2.2 in Glaucoma Surgery

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2023

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Cilioscleral Interposition Device
    • Any patients corresponding to inclusion / exclusion criteria

Clinical Trial Outcome Measures

Primary Measures

  • Assess post-op IOP reduction
    • Time Frame: 12 months
    • Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of POAG Schafer 1 to 4 – Medicated IOP ≥ 21 Exclusion Criteria:

  • Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma – naive of any prior glaucoma surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ciliatech
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julian GARCIA FEIJOO, Pr, Principal Investigator, Clinica San Carlos
  • Overall Contact(s)
    • Olivier BENOIT, +33635550153, o.benoit@cilia.tech

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