A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra
Not Applicable
Terminated
- Conditions
- Glaucoma, Open-Angle
- Registration Number
- NCT03255798
- Lead Sponsor
- Glaukos Corporation
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 20% IOP reduction Month 12 IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg
- Secondary Outcome Measures
Name Time Method IOP less than or equal to 18 mm Hg Month 12 IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg
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 molecular mechanisms underlie the efficacy of second generation iStents in micro-bypass stent therapy for open-angle glaucoma?
How does the combination of two second generation iStents and one iStent Supra compare to traditional trabecular meshwork bypass procedures in open-angle glaucoma management?
Which biomarkers are associated with successful intraocular pressure reduction following micro-bypass stent implantation in mild to moderate open-angle glaucoma patients?
What are the potential adverse events and management strategies for suprachoroidal stent implantation in conjunction with micro-bypass stents for glaucoma treatment?
Are there any combination approaches involving second generation iStents and other glaucoma therapies like prostaglandin analogs or beta-blockers that enhance therapeutic outcomes in open-angle glaucoma?
Trial Locations
- Locations (1)
Prof. Dr. med. Carl Erb
🇩🇪Berlin, Germany
Prof. Dr. med. Carl Erb🇩🇪Berlin, Germany