iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Glaukos Corporation475 enrolled

Overview

Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

Study Type

OBSERVATIONAL

Enrollment

475

Conditions

Glaucoma, Open-Angle

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Randomized subject followed for 24 months in the GC-008 study * Able to understand study requirements * Willing to attend scheduled follow-up exams for 5 years post-operatively * Able and willing to provide written informed consent on the IRB approved Informed Consent Form Exclusion Criteria: * None

Locations (24)

Arizona Advanced Eye Research Institute

Glendale, Arizona, United States

Outcomes

Primary Outcomes

iStent inject Placement and Stability

Rate of clinically relevant complications associated with iStent inject placement and stability.

Time frame: 60 Months

Secondary Outcomes

Sight-Threatening Adverse Events

Rate of occurrence of sight-threatening adverse events

Time frame: 60 Months

Data from ClinicalTrials.gov

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