Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01841450

Enrollment

360

Registered

2013-04-26

Start date

2013-07-31

Completion date

2021-11-30

Last updated

2021-10-20

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 assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Detailed description

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

Interventions

DEVICEiStent

Implantation of one iStent in conjunction with cataract surgery

PROCEDURECataract surgery

Cataract surgery alone

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

* mild to moderate primary open-angle glaucoma * currently treated with ocular hypotensive medication * pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses * subject scheduled to undergo cataract surgery

Exclusion criteria

* primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma * retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Other adverse events	36 months	For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.

Other

Measure	Time frame
Diurnal IOP reduction ≥ 20%	Baseline and 24 months

Countries

United States

Outcome results

None listed

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