A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma

Study Overview
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Brief Summary
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To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.

Detailed Description
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CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach

Official Title
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A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Cadence implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 22-80 years of age. moderate to severe refractory glaucoma Able to consent Exclusion Criteria: Women of child-bearing potential Intraocular surgery or laser within the last 3 months Ocular infection or inflammation within the last 6 months or currently active Current use of anti-coagulant therapy History of bleeding disorder or coagulopathies Subject plans to undergo any ocular surgery (including cataract surgery) during the study period History of corneal transplantation History of ICE Syndrome or epithelial ingrowth/downgrowth History of congenital glaucoma Elevated episcleral venous pressure -. Persistent angle closure- Previous glaucoma filtration surgery- -Presence of conjunctival scarring - neovascular glaucoma AC lens or scleral sutured IOL Aphakia inability to DC contact lenses Presence of intraocular silicone oil Vitreous in AC

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cadence<br>Cadence procedure | Device: Cadence implant<br>* CADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of AEs | comparison of intra-operative and post-operative adverse events observed to events reported in published literature, | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Experience Evaluation | An evaluation of the surgical experience using feedback questionnaire to describe specific note of performance characteristics of each implant. | 12 months | 
| Change in IOP | Change in IOP from Screening to M12 | 12 months | 
| Change in IOP Lowering Medications | Change in IOP lowering medications from Screening to M12 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma