NCT03255798
Terminated
Not Applicable
A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent
ConditionsGlaucoma, Open-Angle
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Glaukos Corporation
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- 20% IOP reduction
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra
Detailed Description
Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg
Exclusion Criteria
- •Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200
Outcomes
Primary Outcomes
20% IOP reduction
Time Frame: Month 12
IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg
Secondary Outcomes
- IOP less than or equal to 18 mm Hg(Month 12)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStentsSubjects With Primary Open-angle Glaucoma (POAG)NCT01252888Glaukos Corporation39
Completed
Phase 4
Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStentsSubjects With Primary Open-angle Glaucoma (POAG)NCT01252862Glaukos Corporation40
Completed
Phase 4
Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive AgentsOpen-angle GlaucomaNCT02873806Glaukos Corporation53
Completed
Phase 4
Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive MedicationOpen Angle GlaucomaNCT02868190Glaukos Corporation57
Completed
Not Applicable
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract SurgeryOpen-angle GlaucomaNCT01455467Glaukos Corporation79