Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

Primary Open Angle Glaucoma Clinical Trial

Official title:

Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836042
• Other study ID #: GTS100-PAS
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: May 18, 2015
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Exclusion Criteria:

• Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study

• Patients not previously enrolled in Glaukos Study GC-003

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

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	The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.	80 Month average	Yes