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

Glaukos

Status: Unknown

Conditions: Glaucoma, Open-Angle

Study type: Observational

Funder types: Industry

Identifiers

NCT04624685

IG2M-104-CONT

Details and patient eligibility

About

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

Full description

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).

Enrollment: 475 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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