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

Primary Open-angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841437
• Other study ID #: GTS100-PAR
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: December 14, 2017
• Start date: September 2013
• Est. completion date: June 21, 2016

Study information

• Verified date: August 2017
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: June 21, 2016
• Est. primary completion date: February 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

• Please refer to approved indications in Directions for Use

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Device:
• iStent

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
Primary	Rate of sight-threatening adverse events		36 months
Secondary	Other ocular adverse events		36 months