Clinical trial NCT01836042: Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort
Official title: Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open Angle Glaucoma
Keywords: Primary open-angle glaucoma (POAG)
Trabecular meshwork
iStent
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extended follow-up of subjects previously enrolled in Glaukos Study GC-003

Brief summary: The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Detailed description: The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Eligibility criteria: Inclusion Criteria:

* Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Exclusion Criteria:

* Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
* Patients not previously enrolled in Glaukos Study GC-003

Primary outcomes:
measure: Rate of Sight-threatening Adverse Events
timeFrame: 80 Month average
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Petaluma
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Clemente
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Parker
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Morrow
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: St. Joseph
country: United States
state: Michigan
city: Bloomington
country: United States
state: Minnesota
city: Edina
country: United States
state: Minnesota
city: Independence
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Brookville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Beaumont
country: United States
state: Texas
Study officials:
affiliation: Glaukos Corporation
name: Jeff Wells, PharmD, MBA
role: STUDY_DIRECTOR
affiliation: Wills Eye Institute; Thomas Jefferson University
name: Jay Katz, MD
role: STUDY_CHAIR
References: