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NCT01841450 Clinical Trial

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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01841450
Other study ID # GTS100-PAS2 (Rev1 04-11-2016)
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date November 2021

Study information
Verified date October 2021
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 360
Est. completion date November 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• iStent
Implantation of one iStent in conjunction with cataract surgery
Procedure:
• Cataract surgery
Cataract surgery alone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Diurnal IOP reduction = 20% Baseline and 24 months
Primary Rate of sight-threatening adverse events 36 months
Secondary 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. 36 months
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