A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Inclusion Criteria:

• Diagnosis of primary open-angle glaucoma
• Male or female at least 18 years of age and able to provide written informed consent
• Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
• Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

• Angle closure glaucoma
• Secondary glaucomas
• Prior glaucoma procedures
• Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease