One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
Not Applicable
Completed
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Registration Number
- NCT01517477
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Inclusion Criteria
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on two topical hypotensive medications
Exclusion Criteria
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline 12 Months
- Secondary Outcome Measures
Name Time Method Mean diurnal IOP <18 mmHg at month 12 12 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which iStent trabecular micro-bypass stents reduce intraocular pressure in primary open-angle glaucoma?
How does the efficacy of iStent implantation compare to traditional trabeculectomy in managing primary open-angle glaucoma patients on two topical medications?
Which biomarkers are associated with successful intraocular pressure reduction following iStent implantation in open-angle glaucoma subjects?
What are the potential adverse events and management strategies for iStent devices in primary open-angle glaucoma patients with prior topical hypotensive therapy?
How do iStent micro-bypass stents compare to other minimally invasive glaucoma surgery (MIGS) devices in reducing intraocular pressure for primary open-angle glaucoma?
Trial Locations
- Locations (1)
S.V. Malayan's Ophthalmology Centre
🇦🇲Yerevan, Armenia
S.V. Malayan's Ophthalmology Centre🇦🇲Yerevan, Armenia