Post Approval Study of the CyPass System

Not Applicable

Terminated

Conditions: Primary Open-angle Glaucoma
Cataract

Interventions: Device: CyPass Micro-Stent implanted with CyPass 241-S applier
Procedure: Cataract surgery

Registration Number: NCT03273907

Lead Sponsor: Alcon Research

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 79

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyPass System	Cataract surgery	CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
CyPass System	CyPass Micro-Stent implanted with CyPass 241-S applier	CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36	Up to Month 36 postoperative	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 * 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).

Secondary Outcome Measures

Name	Time	Method
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	Baseline, Month 36 postoperative	Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.
Mean Change in IOP From Baseline at Month 36	Baseline, Month 36 postoperative	Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.
Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36	Month 36 postoperative	Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted.
Percentage of Eyes With Sight-threatening Adverse Events (AEs)	Up to Month 36 postoperative	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.
Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)	Up to Month 36 postoperative	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
Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability	Up to Month 36 postoperative	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