Post Approval Study of the CyPass System

Alcon Research79 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Open-angle Glaucoma Cataract

Interventions

CyPass Micro-Stent implanted with CyPass 241-S applierDEVICE

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.

Cataract surgeryPROCEDURE

Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (20)

Alcon Investigative Site

Phoenix, Arizona, United States

Alcon Investigative Site

Orange, California, United States

Outcomes

Primary Outcomes

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 * 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).

Time frame: Up to Month 36 postoperative

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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). Only one eye per subject was implanted.

Data from ClinicalTrials.gov

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