Post Approval Study of the CyPass System

Alcon

Status: Terminated

Conditions: Cataract; Primary Open-angle Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03273907

GLD122c-C001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

CyPass System

Experimental group

Description:

CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery

Treatment:

Procedure: Cataract surgery

Device: CyPass Micro-Stent implanted with CyPass 241-S applier