NCT01252914
Completed
Phase 4
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Subject With Primary Open-angle Glaucoma (POAG)
- Sponsor
- Glaukos Corporation
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Detailed Description
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with primary open-angle glaucoma (POAG)
- •Subjects on two topical hypotensive medications
Exclusion Criteria
- •Traumatic, uveitic, neovascular, or angle closure glaucoma
- •Fellow eye already enrolled
Outcomes
Primary Outcomes
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
Time Frame: 12 months
Secondary Outcomes
- Mean diurnal Intraocular Pressure < 18 mmHg at month 12(12 months)
Study Sites (1)
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