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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01252888

Enrollment

Registered

2010-12-03

Start date

2010-12-31

Completion date

2016-12-31

Last updated

2022-09-07

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, Glaucoma Open-Angle, Ocular Hypertension, Eye Diseases

Brief summary

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated 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

DEVICEiStents

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) * Subjects 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