NCT01836042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 15, 2016

Completed
Last Updated

April 15, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

April 17, 2013

Results QC Date

June 16, 2015

Last Update Submit

March 16, 2016

Conditions

Primary Open Angle Glaucoma

Keywords

Primary open-angle glaucoma (POAG)Trabecular meshworkiStent

Outcome Measures

Primary Outcomes (1)

  • Rate of Sight-threatening Adverse Events

    The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.

    80 Month average

Study Arms (3)

Randomized iStent

Implantation of one iStent in conjunction with cataract surgery, patients randomized to group

Randomized cataract surgery

Cataract surgery alone, patients randomized to group

Non-randomized iStent

Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Extended follow-up of subjects previously enrolled in Glaukos Study GC-003

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Beverly Hills, California, 90210, United States

Location

Unknown Facility

Petaluma, California, 94954, United States

Location

Unknown Facility

Sacramento, California, 95817, United States

Location

Unknown Facility

San Clemente, California, 92673, United States

Location

Unknown Facility

Santa Maria, California, 93454, United States

Location

Unknown Facility

Parker, Colorado, 80134, United States

Location

Unknown Facility

Boynton Beach, Florida, 33426, United States

Location

Unknown Facility

Miami, Florida, 33176, United States

Location

Unknown Facility

Tampa, Florida, 33603, United States

Location

Unknown Facility

Morrow, Georgia, 30260, United States

Location

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Overland Park, Kansas, 66213, United States

Location

Unknown Facility

Louisville, Kentucky, 40206, United States

Location

Unknown Facility

Baton Rouge, Louisiana, 70806, United States

Location

Unknown Facility

Saint Joseph, Michigan, 49085, United States

Location

Unknown Facility

Bloomington, Minnesota, 55431, United States

Location

Unknown Facility

Edina, Minnesota, 55435, United States

Location

Unknown Facility

Independence, Missouri, 64055, United States

Location

Unknown Facility

Kansas City, Missouri, 64133, United States

Location

Unknown Facility

Las Vegas, Nevada, 89121, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27101, United States

Location

Unknown Facility

Cincinnati, Ohio, 45242, United States

Location

Unknown Facility

Brookville, Pennsylvania, 15825, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15122, United States

Location

Unknown Facility

Beaumont, Texas, 77702, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Results Point of Contact

Title
Jeff Wells, PharmD, MBA, RAC
Organization
Glaukos
jwells@glaukos.com
949-367-9600

Study Officials

  • Jeff Wells, PharmD, MBA

    Glaukos Corporation

    STUDY DIRECTOR

  • Jay Katz, MD

    Wills Eye Institute; Thomas Jefferson University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 15, 2016

Results First Posted

April 15, 2016

Record last verified: 2016-03

Locations

US(26)