Trial | NCT00913029  Report issue

Title

Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)
A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    192
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.
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
Study Started
May 31
2009
Primary Completion
Sep 30
2012
Study Completion
Sep 30
2012
Last Update
May 20
2015
Estimate

Device iStent

iStent

  • Other names: stent, Trabecular micro bypass

Drug latanoprost/timolol

Combination latanoprost/timolol

Stent Active Comparator

One hundred patients will be randomized to implantation of two G2 stents in at least one eye.

Medication Active Comparator

One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.

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
No Results Posted