Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
Phase 4
Completed
- Conditions
- Subjects With Primary Open-angle Glaucoma (POAG)
- Interventions
- Device: iStents
- Registration Number
- NCT01252888
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.
- Detailed Description
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Two iStent devices and medication iStents Implantation of two iStents through small temporal clear corneal incision
- Primary Outcome Measures
Name Time Method mean diurnal 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
Trial Locations
- Locations (1)
S.V. Malayna's Ophthalmology Centre
🇦🇲Yerevan, Armenia