Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01841437

Enrollment

191

Registered

2013-04-26

Start date

2013-09-30

Completion date

2016-06-21

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

Primary Open-angle Glaucoma

Keywords

Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent

Brief summary

The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

Interventions

DEVICEiStent

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Consecutive subjects in whom implantation of the iStent is attempted

Exclusion criteria

* Please refer to approved indications in Directions for Use

Design outcomes

Primary

Measure	Time frame
Rate of sight-threatening adverse events	36 months

Secondary

Measure	Time frame
Other ocular adverse events	36 months

Countries

United States

Outcome results

None listed

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