Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
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ClinicalTrials.gov Identifier: NCT01461291 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 28, 2011
Last Update Posted
: April 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Open-angle Glaucoma | Device: iStent inject Procedure: Cataract surgery | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery |
Actual Study Start Date : | November 30, 2011 |
Actual Primary Completion Date : | August 4, 2017 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: iStent inject
Implantation of two GTS400 stents using G2-M-IS iStent inject
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Device: iStent inject
Implantation of two GTS400 stents using G2-M-IS iStent inject
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Active Comparator: Cataract surgery
Cataract surgery alone
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Procedure: Cataract surgery
Cataract surgery alone
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- ≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ]
- Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ]
- Safety follow-up post-PMA to be through 36 months [ Time Frame: 36 months ]

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mild to moderate open-angle glaucoma
- Characteristics consistent with mild/moderate glaucoma
- Use of one (1) to three (3) medications at time of screening exam
Exclusion Criteria:
- Pigmentary or pseudoexfoliative glaucoma
- Prior incisional glaucoma surgery

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): NCT01461291

Responsible Party: | Glaukos Corporation |
ClinicalTrials.gov Identifier: | NCT01461291 History of Changes |
Other Study ID Numbers: |
GC-008 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | April 2, 2018 |
Last Verified: | March 2018 |
Keywords provided by Glaukos Corporation:
Primary open-angle glaucoma POAG Trabecular meshwork iStent inject |
Additional relevant MeSH terms:
Glaucoma Cataract Glaucoma, Open-Angle |
Ocular Hypertension Eye Diseases Lens Diseases |