A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
NCT ID: NCT00323284
Last Updated: 2018-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2005-06-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A--iStent plus Cataract Surgery
iStent plus Cataract Surgery
iStent plus Cataract Surgery
ab interno trabecular bypass stent surgery
B--Cataract Surgery Only
Cataract Surgery only
Cataract surgery only
Cataract surgery only
Interventions
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iStent plus Cataract Surgery
ab interno trabecular bypass stent surgery
Cataract surgery only
Cataract surgery only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Angle closure glaucoma
* Fellow eye already enrolled
18 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Wells, PharmD, MBA
Role: STUDY_DIRECTOR
Glaukos Corporation
Locations
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Assil Eye Institute
Beverly Hills, California, United States
North Bay Eye Associates Inc
Petaluma, California, United States
Ellison Ambulatory Care Center
Sacramento, California, United States
Harvard Eye Associates
San Clemente, California, United States
Shepard Eye Center
Santa Maria, California, United States
Glaucoma Consultants of Colorado
Littleton, Colorado, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States
The Center for Excellence in Eye Care
Miami, Florida, United States
International Eye Center
Tampa, Florida, United States
Clayton Eye Center
Morrow, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Stiles Eyecare Excellence
Overland Park, Kansas, United States
The Eye Care Institute Building
Louisville, Kentucky, United States
Williamson Nelson Eye Center
Baton Rouge, Louisiana, United States
Kresge Eye Institute
Detroit, Michigan, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
Chu Vision Institute
Edina, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Discover Vision Centers
Independence, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
The Shepherd Eye Center
Las Vegas, Nevada, United States
Glaucoma Consultants of Capital Region
Slingerlands, New York, United States
Donald J. Digby and Associates
Greensboro, North Carolina, United States
James Branch MD
Winston-Salem, North Carolina, United States
Cinicinnati Eye Institute
Cincinnati, Ohio, United States
Laurel Eye Center
Brookville, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Associates in Ophthalmology
Pittsburgh, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Southeast Texas Medical Association, L.L.P.
Beaumont, Texas, United States
Countries
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References
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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.
Craven 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.
Other Identifiers
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GC-003
Identifier Type: -
Identifier Source: org_study_id
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