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

Glaukos Corporation360 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

Primary Open Angle Glaucoma

Interventions

iStentDEVICE

Implantation of one iStent in conjunction with cataract surgery

Cataract surgeryPROCEDURE

Cataract surgery alone

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (14)

Unnamed facility

Irvine, California, United States

Unnamed facility

Montebello, California, United States

Unnamed facility

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Rate of sight-threatening adverse events

Time frame: 36 months

Secondary Outcomes

Other adverse events

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.

Time frame: 36 months

Data from ClinicalTrials.gov

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