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

Not Applicable

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: iStent; Procedure: Cataract surgery

• Registration Number: NCT01841450
• Lead Sponsor: Glaukos Corporation

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.

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Study Start: 2013-07
• Primary Completion: 2021-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-20
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStent	iStent	Implantation of one iStent in conjunction with cataract surgery
Cataract surgery	Cataract surgery	Cataract surgery alone

Primary Outcome Measures

Name	Time	Method
Rate of sight-threatening adverse events	36 months

Secondary Outcome Measures

Name	Time	Method
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.