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Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

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: NCT01841450
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

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

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: iStent Procedure: Cataract surgery Phase 4

Detailed Description:
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Study Start Date : July 2013
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arm Intervention/treatment
Experimental: iStent
Implantation of one iStent in conjunction with cataract surgery
Device: iStent
Implantation of one iStent in conjunction with cataract surgery
Other Name: GTS100

Active Comparator: Cataract surgery
Cataract surgery alone
Procedure: Cataract surgery
Cataract surgery alone




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

Secondary Outcome Measures :
  1. Other adverse events [ Time Frame: 36 months ]
    For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.


Other Outcome Measures:
  1. Diurnal IOP reduction ≥ 20% [ Time Frame: Baseline and 24 months ]


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to moderate primary open-angle glaucoma
  • currently treated with ocular hypotensive medication
  • pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
  • subject scheduled to undergo cataract surgery

Exclusion Criteria:

  • primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
  • retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

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): NCT01841450


Locations
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United States, California
Irvine, California, United States, 92604
Montebello, California, United States, 90640
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Kentucky
Edgewood, Kentucky, United States, 41017
Louisville, Kentucky, United States, 40217
United States, Michigan
Jackson, Michigan, United States, 49202
Saint Joseph, Michigan, United States, 49085
United States, Missouri
Kansas City, Missouri, United States, 64151
Saint Louis, Missouri, United States, 63131
United States, North Carolina
Winston-Salem, North Carolina, United States, 27101
United States, Ohio
Cincinnati, Ohio, United States, 45242
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Kingston, Pennsylvania, United States, 18704
Sponsors and Collaborators
Glaukos Corporation

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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01841450     History of Changes
Other Study ID Numbers: GTS100-PAS2 (Rev1 04-11-2016)
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
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