Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01252862

Enrollment

Registered

2010-12-03

Start date

2010-12-31

Completion date

2016-12-31

Last updated

2017-12-18

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

Conditions

Subjects With Primary Open-angle Glaucoma (POAG)

Keywords

Open angle, Glaucoma, Surgery, Ocular Hypertension, eye diseases

Brief summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Detailed description

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Interventions

DEVICEiStent

Implantation of two iStents through a small temporal clear corneal incision

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Diagnosed with primary open-angle glaucoma (POAG) * Subject on one topical hypotensive medication

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
IOP < 18 mm Hg at Month 12	12 months

Countries

Armenia

Outcome results

None listed

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