Multicentre, Non-randomised Clinical Study Evaluating the Safety and Efficacy of a Cilioscleral Interposition Device ("CID") v2.2 in Glaucoma Surgery

Ciliatech11 sites in 1 country29 target enrollmentMarch 23, 2023

ConditionsGlaucoma, Open-Angle Glaucoma, Narrow Angle

InterventionsCilioscleral Interposition Device

Overview

Phase: N/A
Intervention: Cilioscleral Interposition Device
Conditions: Glaucoma, Open-Angle
Sponsor: Ciliatech
Enrollment: 29
Locations: 11
Primary Endpoint: Assess post-op IOP reduction
Status: Active, Not Recruiting
Last Updated: 10 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Detailed Description

29 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.

Registry

clinicaltrials.gov

Start Date

March 23, 2023

End Date

September 1, 2028

Last Updated

10 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ciliatech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To be included in the study, all patients must meet all the following inclusion criteria:
•18 years or older
•Able to understand study requirements
•Able and willing:
•To provide written consent on the EC-approved Informed Consent Form,
•To comply with all study requirements, including required study follow-up visits' agenda
•Glaucoma (angle from 1 to 4 according to Schaffer grade), including pseudo exfoliative and pigmentary glaucoma, which meets the following:
•Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p\<5% level as defined by the instrument's built-in age-adjusted normative database,
•Glaucoma visual field with -15 \< MD \< 0dB (Humphrey) or 0 \< MD \< 15 dB (Octopus)
•Pharmacological treatments: glaucoma not adequately controlled by 1 to 3 different IOP-lowering medication(s), given each for at least one month prior to Screening,

Exclusion Criteria

•Patients will not participate in this clinical study if they meet any of the following criteria:
•Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
•Patient already included in another study
•A person protected by law (temporary or permanent guardianship) or not capable of discernment
•Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)
•Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)
•With uncontrolled systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits (e.g. inability to reliably complete visual field testing over the course of the study, or take glaucoma medications (e.g. Parkinson's disease), or uncontrolled systemic disease (diabetes, hypertension) that could compromise participation in the study, …)
•Who have a new or modified prescription for a systemic treatment that could influence IOP within one month prior to inclusion, or who are aware of a future change in their systemic treatment, or if their medical condition indicates that their systemic treatment may change in the future
•Chemotherapy in the last 6 months before surgery
•Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)

Arms & Interventions

Cilioscleral Interposition Device

Any patients corresponding to inclusion / exclusion criteria

Intervention: Cilioscleral Interposition Device

Outcomes

Primary Outcomes

Assess post-op IOP reduction

Time Frame: 6 months

Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery

Assess post-op IOP reduction

Time Frame: 6 months

Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery

Secondary Outcomes

Change in medicated IOP and IOP-lowering treatments(baseline and 12, 24, and 26 months after surgery)
Decrease in IOP from baseline up to 36 months post-operatively(baseline up to 6, 12, 24, and 36 months post-operatively)
Mean medicated IOP(baseline, 6, 12, 24, and 36 months after surgery)
Mean number of IOP lowering treatments(baseline, 6, 12, 24, and 36 months after surgery)
Absolute success rate: proportion of med-free eyes(6, 12, 24, and 36 months)
Qualified success rate: proportion of eyes with IOP decrease(6, 12, 24, 36 months)
Rate of patients with reduction of IOP at each visit(36 months)
Proportion of eyes free of ocular hypertensives(6, 12, 24, and 36 months after surgery)
Proportion of eyes with IOP between 6 and 18 mmHg with and without IOP lowering treatments(6, 12, 24 and 36 months after surgery)
Proportion of eyes with IOP between 6 and 16 mmHg with and without IOP lowering treatments(6, 12, 24 and 36 months after surgery)
Number of adjunctive therapies(36 months)
Patient rate without filtering bleb(6, 12, 24 and 36 months after surgery)
Surgical implantation evaluation(1 day)
Assess patient experience post-operatively(1 and 7 days, then at 1, 6, 12, 24 and 36 months after surgery)
Describe patient satisfaction post-operatively(1, 6, 12, 24 and 36 months after surgery)
Assess patient quality of life(1, 6, 12, 24 and 36 months after surgery)
Rate of device related ocular adverse events and adverse device effects(up to 36 months)
Safety examination findings(up to 36 months)
Rate of Best Corrected Visual Acuity(6, 12, 24 and 36 months after surgery)
Rate of Visual Field Mean Deviation variation(6, 12, 24 and 36 months after surgery)
Rate of C/D ratio mean deviation(6, 12, 24 and 36 months after surgery)
Rate of sight threatening events(up to 36 months)
Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT)(6, 12, 24 and 36 months after surgery)
Rate of occurrence of SUPRAFLOW V2.2 movements(6, 12, 24 and 36 months after surgery)