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

Glaukos

Status: Completed

Conditions: Primary Open Angle Glaucoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01836042

GTS100-PAS

Details and patient eligibility

About

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.

Full description

The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Enrollment: 108 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

108 participants in 3 patient groups

Randomized iStent

Description:

Implantation of one iStent in conjunction with cataract surgery, patients randomized to group

Randomized cataract surgery

Description:

Cataract surgery alone, patients randomized to group

Non-randomized iStent

Description:

Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group