Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
NCT03639870 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2021-04-23
Summary
Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.
Conditions
Interventions
- DEVICE
-
Model iS3 three-stent trabecular micro-bypass system
Provided in Arm/Group descriptions.
Sponsors & Collaborators
-
Glaukos Corporation
lead INDUSTRY
Principal Investigators
-
Kerry Stephens, O.D. · Glaukos Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-10
- Primary Completion
- 2021-09-30
- Completion
- 2021-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
NCT01461278 ·Status: COMPLETED ·Phase: NA
-
Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
NCT01841450 ·Status: UNKNOWN ·Phase: NA
-
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
NCT00323284 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT01455467 ·Status: COMPLETED ·Phase: NA
-
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
NCT01461291 ·Status: COMPLETED ·Phase: NA
-
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
NCT01517477 ·Status: COMPLETED ·Phase: NA
-
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
NCT00326014 ·Status: COMPLETED ·Phase: PHASE4
-
Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
NCT02327312 ·Status: TERMINATED ·Phase: NA
-
Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication
NCT02868190 ·Status: COMPLETED ·Phase: PHASE4
-
AqueSys Microfistula Implant in Refractory Glaucoma
NCT01640756 ·Status: COMPLETED ·Phase: PHASE3
-
Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
NCT01444105 ·Status: COMPLETED ·Phase: NA
-
Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
NCT01252862 ·Status: COMPLETED ·Phase: PHASE4
-
Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
NCT03255785 ·Status: COMPLETED ·Phase: NA
-
Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents
NCT01456390 ·Status: COMPLETED ·Phase: NA
-
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
NCT01252888 ·Status: COMPLETED ·Phase: PHASE4
-
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
NCT01252849 ·Status: COMPLETED ·Phase: NA
-
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
NCT01443988 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
NCT00326066 ·Status: COMPLETED ·Phase: NA
-
NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
NCT01408472 ·Status: COMPLETED ·Phase: PHASE1
-
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
NCT01444040 ·Status: COMPLETED ·Phase: PHASE4
-
Hydrus Microstent for Refractory Open-Angle Glaucoma
NCT03267134 ·Status: COMPLETED ·Phase: NA
-
Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
NCT07228221 ·Status: RECRUITING ·Phase: PHASE4
-
A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra
NCT03255798 ·Status: TERMINATED ·Phase: NA
-
Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent
NCT03647033 ·Status: COMPLETED ·Phase: NA
-
Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived
NCT03469297 ·Status: COMPLETED ·Phase: NA