Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Study Details
Study Description
Brief Summary
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: iStent inject Implantation of two GTS400 stents using G2-M-IS iStent inject |
Device: iStent inject
Implantation of two GTS400 stents using G2-M-IS iStent inject
|
Active Comparator: Cataract surgery Cataract surgery alone |
Procedure: Cataract surgery
Cataract surgery alone
|
Outcome Measures
Primary Outcome Measures
- ≥ 20% Reduction in Intraocular Pressure (IOP) [Baseline and Month 24]
Secondary Outcome Measures
- Diurnal IOP Reduction from Baseline [Baseline and Month 24]
Other Outcome Measures
- Safety follow-up post-PMA to be through 36 months [36 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Eye Centers of Racine and Kenosha | Racine | Wisconsin | United States | 53405 |
Sponsors and Collaborators
- Glaukos Corporation
Investigators
- Study Chair: Kerry Stephens, O.D., Glaukos Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GC-008