NCT03273907

Post Approval Study of the CyPass System

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open-angle Glaucoma
• Cataract

Interventions

Type	Name	Description
DEVICE	CyPass Micro-Stent implanted with CyPass 241-S applier	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.
PROCEDURE	Cataract surgery	Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit

Timeline

• Start date: 2017-10-12
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2017-09-06
• Last updated: 2024-02-16
• Results posted: 2022-09-21

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study