Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01252849

Enrollment

119

Registered

2010-12-03

Start date

2010-12-31

Completion date

2019-10-08

Last updated

2022-08-31

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

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases

Brief summary

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Interventions

DEVICEiStent

Implantation of One iStent through a small temporal clear corneal incision.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

iStent 1, 2, or 3 stents

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Diagnosed with primary open-angle glaucoma (POAG) * Subject on two topical hypotensive medications

Exclusion criteria

* Traumatic, uveitic, neovascular, or angle closure glaucoma * Fellow eye already enrolled

Design outcomes

Primary

Measure	Time frame
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline	12 Months

Secondary

Measure	Time frame
Mean diurnal IOP <18 mmHg at month 12	12 months

Countries

Armenia

Outcome results

None listed

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