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NCT04624685 Clinical Trial

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

Glaucoma, Open-Angle Clinical Trial

Official title:
iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04624685
Other study ID # IG2M-104-CONT
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 15, 2020
Est. completion date December 2021

Study information
Verified date October 2021
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 475
Est. completion date December 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Keystone Research Austin Texas
United States Argus Research Cape Coral Florida
United States Chicago Eye Specialists Chicago Illinois
United States Kresge Eye Institute / Wayne State University Detroit Michigan
United States Vold Vision, PLLC Fayetteville Arkansas
United States Eye Center of northern Colorado, PC Fort Collins Colorado
United States Ophthalmology Associates Fort Worth Texas
United States Arizona Advanced Eye Research Institute Glendale Arizona
United States Discover Vision Centers Independence Missouri
United States D'Ambrosio Eye Care Lancaster Massachusetts
United States Clayton Eye Clinical Research, LLC. Morrow Georgia
United States Oklahoma eye Surgeons, PLLC Oklahoma City Oklahoma
United States Arbor Center for Eye Care Orland Park Illinois
United States Stiles Eyecare Excellence Overland Park Kansas
United States The Eye Center of Racine and Kenosha Racine Wisconsin
United States Vistar Eye Center Roanoke Virginia
United States Parkhurst Nuvision San Antonio Texas
United States R and R Eye Resarch, LLC San Antonio Texas
United States North Bath Eye Associates, Inc. Santa Rosa California
United States Glaucoma Consultants of the Capital Region Slingerlands New York
United States Northern New Jersey Eye Institute South Orange New Jersey
United States Spokane Eye Clinical Research Spokane Washington
United States International Research Center Tampa Florida
United States Center for Sight Venice Florida

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Secondary Surgical Interventions Rate of Secondary Surgical Interventions 60 Months
Other Adverse Events Rate of other adverse Events 60 Months
Primary iStent inject Placement and Stability Rate of clinically relevant complications associated with iStent inject placement and stability. 60 Months
Secondary Sight-Threatening Adverse Events Rate of occurrence of sight-threatening adverse events 60 Months
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