A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
1 other identifier
interventional
240
1 country
31
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2005
Longer than P75 for phase_3
31 active sites
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
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 6, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
October 4, 2012
CompletedJanuary 12, 2018
March 1, 2016
4.1 years
May 6, 2006
September 4, 2012
December 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months
12 months
Secondary Outcomes (1)
Efficacy
12 months
Study Arms (2)
A--iStent plus Cataract Surgery
ACTIVE COMPARATORiStent plus Cataract Surgery
B--Cataract Surgery Only
ACTIVE COMPARATORCataract Surgery only
Interventions
ab interno trabecular bypass stent surgery
Cataract surgery only
Eligibility Criteria
You may qualify if:
- Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
- Subject on at least one glaucoma medication
- Able and willing to attend follow up visits for two years post operative
- Able and willing to sign informed consent
You may not qualify if:
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
- Fellow eye already enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Assil Eye Institute
Beverly Hills, California, 90210, United States
North Bay Eye Associates Inc
Petaluma, California, 94954, United States
Ellison Ambulatory Care Center
Sacramento, California, 95817, United States
Harvard Eye Associates
San Clemente, California, 92673, United States
Shepard Eye Center
Santa Maria, California, 93454, United States
Glaucoma Consultants of Colorado
Littleton, Colorado, 80120, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426, United States
The Center for Excellence in Eye Care
Miami, Florida, 33176, United States
International Eye Center
Tampa, Florida, 33603, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Indiana University
Indianapolis, Indiana, 46260, United States
Stiles Eyecare Excellence
Overland Park, Kansas, 66213, United States
The Eye Care Institute Building
Louisville, Kentucky, 40206, United States
Williamson Nelson Eye Center
Baton Rouge, Louisiana, 70806, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
Chu Vision Institute
Edina, Minnesota, 55435, United States
University of Minnesota
Minneapolis, Minnesota, 55404, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Discover Vision Centers
Independence, Missouri, 64055, United States
Silverstein Eye Centers
Kansas City, Missouri, 64133, United States
The Shepherd Eye Center
Las Vegas, Nevada, 89121, United States
Glaucoma Consultants of Capital Region
Slingerlands, New York, 12159, United States
Donald J. Digby and Associates
Greensboro, North Carolina, 27408, United States
James Branch MD
Winston-Salem, North Carolina, 27101, United States
Cinicinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Laurel Eye Center
Brookville, Pennsylvania, 15825, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Associates in Ophthalmology
Pittsburgh, Pennsylvania, 15122, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213, United States
Southeast Texas Medical Association, L.L.P.
Beaumont, Texas, 77702, United States
Related Publications (2)
Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15.
PMID: 20828829RESULTCraven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025.
PMID: 22814041RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Open label given no way to mask treatment group to surgeon and visibility of iStent device upon gonioscopy.
Results Point of Contact
- Title
- Jeff Wells, Sr. VP, Clinical, Regulatory, and Quality Affairs
- Organization
- Glaukos
Study Officials
- STUDY DIRECTOR
Jeff Wells, PharmD, MBA
Glaukos Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- IOP measurement
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2006
First Posted
May 9, 2006
Study Start
June 1, 2005
Primary Completion
July 1, 2009
Study Completion
March 1, 2010
Last Updated
January 12, 2018
Results First Posted
October 4, 2012
Record last verified: 2016-03