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

This study to evaluate the safety and efficacy of the CyPass Implant 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