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Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841437
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

Condition or disease Intervention/treatment
Primary Open-angle Glaucoma Device: iStent

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Study Type : Observational [Patient Registry]
Actual Enrollment : 191 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
Study Start Date : September 2013
Actual Primary Completion Date : February 16, 2016
Actual Study Completion Date : June 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Group/Cohort Intervention/treatment
iStent Device: iStent



Primary Outcome Measures :
  1. Rate of sight-threatening adverse events [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Other ocular adverse events [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites
Criteria

Inclusion Criteria:

  • Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

  • Please refer to approved indications in Directions for Use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841437


Locations
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United States, California
Chico, California, United States, 95926
Huntington Beach, California, United States, 92647
Napa, California, United States, 94558
Santa Maria, California, United States, 93454
Ventura, California, United States, 93003
United States, Colorado
Parker, Colorado, United States, 80134
United States, Maine
Portland, Maine, United States, 04102
United States, Massachusetts
Quincy, Massachusetts, United States, 02169
United States, Minnesota
Bloomington, Minnesota, United States, 55431
United States, New Jersey
Westwood, New Jersey, United States, 07675
United States, North Carolina
Durham, North Carolina, United States, 27710
Fayetteville, North Carolina, United States, 28304
Southern Pines, North Carolina, United States, 28387
United States, Ohio
Brecksville, Ohio, United States, 44141
Youngstown, Ohio, United States, 44502
United States, South Carolina
Ladson, South Carolina, United States, 29456
United States, South Dakota
Sioux Falls, South Dakota, United States, 57108
United States, Wisconsin
Appleton, Wisconsin, United States, 54914
Sponsors and Collaborators
Glaukos Corporation

Additional Information:

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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01841437     History of Changes
Other Study ID Numbers: GTS100-PAR
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: August 2017
Keywords provided by Glaukos Corporation:
Primary open-angle glaucoma (POAG)
Trabecular meshwork
iStent
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases