Clinical trial NCT04624685: iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study
Official title: iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma, Open-Angle
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 475
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 475 eyes of 475 subjects. This is based on the number of randomized subjects in the GC-008 study followed for 24 months.

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).

Eligibility criteria: 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

Primary outcomes:
measure: iStent inject Placement and Stability
timeFrame: 60 Months
Secondary outcomes:
measure: Sight-Threatening Adverse Events
timeFrame: 60 Months
Other outcomes:
measure: Secondary Surgical Interventions
timeFrame: 60 Months
measure: Adverse Events
timeFrame: 60 Months
Locations:
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision, PLLC
state: Arkansas
city: Santa Rosa
country: United States
facility: North Bath Eye Associates, Inc.
state: California
city: Fort Collins
country: United States
facility: Eye Center of northern Colorado, PC
state: Colorado
city: Cape Coral
country: United States
facility: Argus Research
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Venice
country: United States
facility: Center for Sight
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC.
state: Georgia
city: Chicago
country: United States
facility: Chicago Eye Specialists
state: Illinois
city: Orland Park
country: United States
facility: Arbor Center for Eye Care
state: Illinois
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence
state: Kansas
city: Lancaster
country: United States
facility: D'Ambrosio Eye Care
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute / Wayne State University
state: Michigan
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute
state: New Jersey
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma eye Surgeons, PLLC
state: Oklahoma
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Parkhurst Nuvision
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Resarch, LLC
state: Texas
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Racine
country: United States
facility: The Eye Center of Racine and Kenosha
state: Wisconsin
Study officials:
References: