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

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.

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.

Preoperative Inclusion Criteria:

• Diagnosis of primary open angle glaucoma (POAG)
• Mean diurnal unmedicated IOP of 21 - 33 mmHg
• Normal anterior chamber angle anatomy at site of implantation
• Operable age-related cataract

Exclusion Criteria:

• Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
• Significant risk associated with washout of ocular hypotensive medication
• Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
• Previous corneal surgery
• Clinically significant ocular pathology, other than cataract and glaucoma
• Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma