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

• Conditions: Glaucoma, Open-Angle

• Registration Number: NCT04624685
• Lead Sponsor: Glaukos Corporation

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Primary Completion: 2021-01-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-20
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 475

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iStent inject Placement and Stability	60 Months	Rate of clinically relevant complications associated with iStent inject placement and stability.

Secondary Outcome Measures

Name	Time	Method
Sight-Threatening Adverse Events	60 Months	Rate of occurrence of sight-threatening adverse events

Trial Locations

Locations (24)

Stiles Eyecare Excellence; 🇺🇸 Overland Park, Kansas, United States

Chicago Eye Specialists; 🇺🇸 Chicago, Illinois, United States

Kresge Eye Institute / Wayne State University; 🇺🇸 Detroit, Michigan, United States

R and R Eye Resarch, LLC; 🇺🇸 San Antonio, Texas, United States

Arizona Advanced Eye Research Institute; 🇺🇸 Glendale, Arizona, United States

Vold Vision, PLLC; 🇺🇸 Fayetteville, Arkansas, United States

North Bath Eye Associates, Inc.; 🇺🇸 Santa Rosa, California, United States

Eye Center of northern Colorado, PC; 🇺🇸 Fort Collins, Colorado, United States

Argus Research; 🇺🇸 Cape Coral, Florida, United States

International Research Center; 🇺🇸 Tampa, Florida, United States

Center for Sight; 🇺🇸 Venice, Florida, United States

Clayton Eye Clinical Research, LLC.; 🇺🇸 Morrow, Georgia, United States

Arbor Center for Eye Care; 🇺🇸 Orland Park, Illinois, United States

D'Ambrosio Eye Care; 🇺🇸 Lancaster, Massachusetts, United States

Discover Vision Centers; 🇺🇸 Independence, Missouri, United States

Northern New Jersey Eye Institute; 🇺🇸 South Orange, New Jersey, United States

Glaucoma Consultants of the Capital Region; 🇺🇸 Slingerlands, New York, United States

Keystone Research; 🇺🇸 Austin, Texas, United States

Ophthalmology Associates; 🇺🇸 Fort Worth, Texas, United States

Parkhurst Nuvision; 🇺🇸 San Antonio, Texas, United States

Vistar Eye Center; 🇺🇸 Roanoke, Virginia, United States

The Eye Center of Racine and Kenosha; 🇺🇸 Racine, Wisconsin, United States

Spokane Eye Clinical Research; 🇺🇸 Spokane, Washington, United States

Oklahoma eye Surgeons, PLLC; 🇺🇸 Oklahoma City, Oklahoma, United States