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

Glaukos Corporation108 enrolled

Overview

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.

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%.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Primary Open Angle Glaucoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (26)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: 80 Month average

Data from ClinicalTrials.gov

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