Clinical Trials Logo
  1. Home
  2. Open-Angle Glaucoma
  3. NCT00721968

Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Open-angle Glaucoma Clinical Trial

Official title:
A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery

Clinical Trial Summary

To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.

Clinical Trial Description

The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00721968
Study type Interventional
Source Glaukos Corporation
Contact
Status Completed
Phase Phase 3
Start date March 2007
Completion date August 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT01443988 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost Phase 4
Completed NCT01444040 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Phase 4
Completed NCT01455467 - Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery N/A
Completed NCT01444105 - Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty N/A
Completed NCT01456390 - Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents N/A
Completed NCT01487655 - Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients N/A
Completed NCT01415401 - Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada Phase 4
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4
Completed NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2
Completed NCT00759239 - Phase IV Randomised Double-masked Clinical Trial: Assessing Morning Versus Evening Dosing of a Fixed Dose Combination of Travoprost 0.004% / Timolol Maleate 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension Phase 4
Completed NCT00397241 - 24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations Phase 4
Completed NCT00918346 - Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation Phase 3
Completed NCT00273481 - Cosopt Versus Xalacom Phase 4
Completed NCT00716742 - Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG) N/A
Completed NCT02558400 - Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Withdrawn NCT03648229 - African Glaucoma Laser Trial Phase 4
Completed NCT01978600 - Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension Phase 4
Completed NCT01699464 - A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months Phase 2