Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
Not Applicable
Completed
- Conditions
- Open-angle Glaucoma
- Registration Number
- NCT01455467
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
- Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
Exclusion Criteria
- Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
- Prior stent implantations (study eye)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP 12 Months
- Secondary Outcome Measures
Name Time Method
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 trabecular micro-bypass stents reduce intraocular pressure in open-angle glaucoma?
How does the use of one or two iStents during cataract surgery compare to standard anti-glaucoma medications in managing primary open-angle glaucoma?
Which biomarkers are associated with successful IOP reduction following trabecular micro-bypass stent implantation in glaucoma patients?
What are the known adverse events associated with trabecular micro-bypass stents and how are they managed in clinical practice?
Are there combination approaches involving trabecular micro-bypass stents and topical hypotensive medications that improve outcomes in primary open-angle glaucoma?
Trial Locations
- Locations (1)
S.V. Malayan Ophthalmological Center
🇦🇲Yerevan, Armenia
S.V. Malayan Ophthalmological Center🇦🇲Yerevan, Armenia