Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation 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

Conditions
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Primary Open Angle Glaucoma (POAG)

Intervention / Treatment
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* Device: CyPass Micro-Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of POAG Medicated IOP ≥ 21 and ≤ 35 mmHg Use of 1 - 4 topical IOP lowering medications Exclusion Criteria: Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma Use of oral hypotensive medication treatment for glaucoma Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure Clinically significant ocular pathology other than POAG

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyPass Micro-Stent<br>Subjects receive the CyPass Micro-Stent | Device: CyPass Micro-Stent<br>* The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage. | Baseline; Month 12 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication | Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage. | Month 12 postoperative | 
| Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline | The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit. | Baseline, Month 12 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure