Post Approval Study of the CyPass System

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).

Detailed Description
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Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.

Official Title
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Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery

Conditions
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Primary Open-angle Glaucoma, Cataract

Intervention / Treatment
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* Device: CyPass Micro-Stent implanted with CyPass 241-S applier
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits Diagnosis of primary open angle glaucoma (POAG) Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg An operable age-related cataract eligible for phacoemulsification Visual acuity as specified in the protocol Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Inability to complete a visual field test prior to surgery Use of ocular hypotensive medication/s, as specified in the protocol Diagnosis of glaucoma other than POAG, as specified in the protocol Other medical conditions, as specified in the protocol Proliferative diabetic retinopathy Previous surgery for retinal detachment Previous corneal surgery Wet age-related macular degeneration Poor vision in the non-study eye not due to cataract Significant ocular inflammation or infection within 30 days of screening visit Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits Women who are pregnant or nursing Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 45 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 System<br>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery | Device: CyPass Micro-Stent implanted with CyPass 241-S applier<br>* CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.<br>Procedure: Cataract surgery<br>* Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 | Device-related complications, as specified in the protocol, included: Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass. Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that: The device is not in the supraciliary space, or There is a clinical sequela resulting from device position including, but not limited to: Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation) Corneal endothelial touch by device Corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVA Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up) | Up to Month 36 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in IOP From Baseline at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement. | Baseline, Month 36 postoperative | 
| Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. | Baseline, Month 36 postoperative | 
| Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). | Month 36 postoperative | 
| Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Sight-threatening adverse events, as specified in the protocol, included: Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more Endophthalmitis Corneal decompensation Retinal detachment Severe choroidal hemorrhage or detachment Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE. | Up to Month 36 postoperative | 
| Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI) | A secondary surgical intervention may have occurred for any of the following reasons: CyPass device explantation associated with CyPass placement and stability CyPass device explantation NOT associated with CyPass placement and stability Unplanned ocular surgical reintervention associated with CyPass placement and stability Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol). Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE | Up to Month 36 postoperative | 
| Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability | A secondary surgical intervention may have occurred for either of the following reasons: CyPass device explantation associated with CyPass placement and stability Unplanned ocular surgical reintervention associated with CyPass placement and stability. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE | Up to Month 36 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CyPass Micro-Stent