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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913029

Acronym

Enrollment

192

Registered

2009-06-03

Start date

2009-05-31

Completion date

2012-09-30

Last updated

2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases, Glaucoma, Open-Angle, Glaucoma

Keywords

primary open angle glaucoma (POAG), OAG, glaucoma

Brief 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.

Detailed description

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

Interventions

DEVICEiStent

iStent

DRUGlatanoprost/timolol

Combination latanoprost/timolol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean intraocular pressure (IOP)	1 year

Countries

Armenia, Austria, France, Germany, Greece, Italy, Poland, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026