NCT01085357

Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 897 (actual)
• Sponsor: Transcend Medical, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.

Detailed description

This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.

Conditions

• Primary Open Angle Glaucoma (POAG)
• Cataract

Interventions

Type	Name	Description
PROCEDURE	Cataract Surgery	Cataract Surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
DEVICE	CyPass Micro-Stent	The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye after completion of cataract surgery.

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-03-11
• Last updated: 2017-05-15
• Results posted: 2016-10-20