Overview

Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Glaukos Corporation
Treatments:
Antihypertensive Agents
Latanoprost
Timolol
Criteria
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 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